Distribution date: 09 January 2007

The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labelling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products to include new warnings and other labelling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labelling for all OTC IAAA drug products. The new labelling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labelling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use.

Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS:  Chapter 3004; ICS:  11)

Regulation Type: Regular notification

Distribution date: 09 January 2007

The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labelling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products to include new warnings and other labelling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labelling for all OTC IAAA drug products. The new labelling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labelling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use.

Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS:  Chapter 3004; ICS:  11)

Regulation Type: Regular notification

Distribution date: 09 January 2007

The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.

Products Covered: Dairy cream: International Classification for Standards (ICS) code 67.100; HS tariff headings 04.02 and 04.03

Regulation Type: Regular notification

Distribution date: 09 January 2007

The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.

Products Covered: Dairy cream: International Classification for Standards (ICS) code 67.100; HS tariff headings 04.02 and 04.03

Regulation Type: Regular notification

Distribution date: 09 January 2007

The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.

Products Covered: Yoghurt: International Classification for Standards (ICS) code 67.100; HS tariff heading 0403.10

Regulation Type: Regular notification

Distribution date: 09 January 2007

The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.

Products Covered: Yoghurt: International Classification for Standards (ICS) code 67.100; HS tariff heading 0403.10

Regulation Type: Regular notification

Distribution date: 09 January 2007

The notified regulation establishes the official methods on physico-chemical analysis of milk and dairy products to be used by Ministry of Agriculture, Livestock and Food Supply's official laboratory (LANAGRO). It revokes Normative Instruction Nº 22 from 14 April 2006.

Products Covered: Milk and dairy products.

Regulation Type: Regular notification

Distribution date: 09 January 2007

The notified regulation establishes the official methods on physico-chemical analysis of milk and dairy products to be used by Ministry of Agriculture, Livestock and Food Supply's official laboratory (LANAGRO). It revokes Normative Instruction Nº 22 from 14 April 2006.

Products Covered: Milk and dairy products.

Regulation Type: Regular notification

Distribution date: 08 January 2007

Health Canada has received a submission to permit the use of the xylanase enzyme from a genetically modified Aspergillus oryzae organism, Aspergillus oryzae JaL 339 (pJal 537) that carries the gene from Thermomyces lanuginosus coding for this enzyme. The xylanase enzyme will be used 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 Aspergillus oryzae JaL 339 (pJal 537). 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: 08 January 2007

Health Canada has received a submission to permit the use of the xylanase enzyme from a genetically modified Aspergillus oryzae organism, Aspergillus oryzae JaL 339 (pJal 537) that carries the gene from Thermomyces lanuginosus coding for this enzyme. The xylanase enzyme will be used 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 Aspergillus oryzae JaL 339 (pJal 537). 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