Regulatory Updates

Distribution date: 15 September 2006

Health Canada has received a submission to permit the use of the xylanase enzyme from a Bacillus subtilis organism, Bacillus subtilis DIDK 0115 (pUB110 OIS2) genetically modified to contain multiple copies of the gene coding for the xylanase enzyme, in the production of bread, flour, whole wheat flour and unstandardized bakery products at levels consistent with good manufacturing practice. Evaluation of available data supports the safety and effectiveness of this xylanase enzyme derived from Bacillus subtilis DIDK 0115 (pUB110 OIS2). The use of this xylanase enzyme derived from this modified micro-organism will benefit the consumer through the availability of quality food products. It will also benefit industry through more efficient and improved manufacturing conditions. Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of this xylanase enzyme derived from the micro-organism specified above in the production of bread, flour, whole wheat flour and unstandardized bakery products at levels consistent with good manufacturing practice. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of the xylanase enzyme, as indicated above, while the regulatory process is undertaken to formally amend the Regulations. A revision to this notification will be published at the start of the amendment process and Members will be given the opportunity at that time to submit comments on this proposed measure.

Products Covered: Xylanase enzyme (ICS: 67.060)

Regulation Type: Regular notification

Distribution date: 15 September 2006

Products Covered: Hair shampoo (HS: 330510;  ICS: 71.100.70)

Regulation Type: Regular notification

Distribution date: 15 September 2006

Products Covered: Hair shampoo (HS: 330510;  ICS: 71.100.70)

Regulation Type: Regular notification

Distribution date: 15 September 2006

Products Covered: Carbon Black used in rubber products (HS: 2803;  ICS: 83.040.20)

Regulation Type: Regular notification

Distribution date: 15 September 2006

Products Covered: Carbon Black used in rubber products (HS: 2803;  ICS: 83.040.20)

Regulation Type: Regular notification

Distribution date: 15 September 2006

Products Covered: Food additives, food enzymes and food flavourings. Numerous positions within HS:  headings 0910, 2103, 2106, 2901 to 2940, 3302, 3507. ICS:  67.220

Regulation Type: Regular notification

Distribution date: 15 September 2006

Products Covered: Food additives, food enzymes and food flavourings. Numerous positions within HS:  headings 0910, 2103, 2106, 2901 to 2940, 3302, 3507. ICS:  67.220

Regulation Type: Regular notification

Distribution date: 15 September 2006

The draft regulation encompasses all situations associated with developing, producing, importing, processing, distributing, exporting and selling external healthcare products and health personnel's duty to report any side effects when using such products.

Products Covered: External healthcare products: Substances or mixtures of substances meant to come into contact with the surface of the body of humans or animals, teeth or mucous membranes in the mouth or nostrils solely or mainly to prevent, relieve or treat health problems not due to disease.

Regulation Type: Regular notification

Distribution date: 15 September 2006

The draft regulation encompasses all situations associated with developing, producing, importing, processing, distributing, exporting and selling external healthcare products and health personnel's duty to report any side effects when using such products.

Products Covered: External healthcare products: Substances or mixtures of substances meant to come into contact with the surface of the body of humans or animals, teeth or mucous membranes in the mouth or nostrils solely or mainly to prevent, relieve or treat health problems not due to disease.

Regulation Type: Regular notification

Distribution date: 15 September 2006

This draft regulation encompasses all situations associated with developing, producing, importing, processing, distributing, exporting and selling of products for cutaneous injection for cosmetic purposes and health personnel's duty to report any side effects when using such products.

Products Covered: Product for cutaneous injection for cosmetic purposes: All substances or combination of substances which are meant to be introduced into the skin of humans or animals to change the appearance in ways other than those encompassed by the regulation of xx.xx.2006 concerning tattooing products.

Regulation Type: Regular notification