Regulatory Updates

Draft of the Eurasian Economic Comission Collegium Decision on amendments to Common sanitary-epidemiological and hygienic requirements for products, subjected to sanitary-epidemiological supervision (control)

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Distribution date: 15 December 2014 | Final date for Comment: 13 February 2015

It was decided to stop developing amendments to Section 1 of Chapter 2 of the Common sanitary-epidemiological and hygienic requirements for products, subjected to sanitary-epidemiological supervision (control), establishing norms for peroxide number for refined deodorized palm-oil (not more than 0.9 mmol of active oxigen/kg).

Products Covered:

Regulation Type: Addendum to Regular Notification

Modification of content/scope of regulation

Bovine Spongiform Encephalopathy (BSE) Import Policy for Bovine Animals and Their Products and By-products and associated annexes

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Distribution date: 15 December 2014 | Final date for Comment: 15 January 2015

The CFIA is updating the Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-Products (herein referred to as BSE Import Policy). Related policies (listed within the BSE Import Policy) will also be updated to align with or refer to this policy. Updates to the BSE Import Policy include: providing the list of definitions in a separate document referenced via hyperlink; revising the list of the Bovine Spongiform Encephalopathy (BSE) status of OIE members such that it reflects the updated Terrestrial Animal Health Code (May 2014) of the OIE (further delineation of the list based on types of cases reported); and listing dates (based on OIE guidelines) which Canada has determined as the effective date of implementation and enforcement of feed bans for all the countries on the lists for negligible and controlled risk for BSE status.

Products Covered: Bovine origin product

Regulation Type: Revision to Regular Notification

Animal diseases Food safety Animal health Human health Bovine Spongiform Encephalopathy (BSE) Transmissible Spongiform Encephalopathy (TSE) Zoonoses

Bovine Spongiform Encephalopathy (BSE) Import Policy for Bovine Animals and Their Products and By-products and associated annexes

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Distribution date: 15 December 2014 | Final date for Comment: 15 January 2015

The CFIA is updating the Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-Products (herein referred to as BSE Import Policy). Related policies (listed within the BSE Import Policy) will also be updated to align with or refer to this policy. Updates to the BSE Import Policy include: providing the list of definitions in a separate document referenced via hyperlink; revising the list of the Bovine Spongiform Encephalopathy (BSE) status of OIE members such that it reflects the updated Terrestrial Animal Health Code (May 2014) of the OIE (further delineation of the list based on types of cases reported); and listing dates (based on OIE guidelines) which Canada has determined as the effective date of implementation and enforcement of feed bans for all the countries on the lists for negligible and controlled risk for BSE status.

Products Covered: Bovine origin product

Regulation Type: Revision to Regular Notification

Animal diseases Food safety Animal health Human health Bovine Spongiform Encephalopathy (BSE) Transmissible Spongiform Encephalopathy (TSE) Zoonoses

Notice of Consultation- Prescription Drug List (PDL): Mometasone Furoate Monohydrate (2 pages, in English and French)

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Distribution date: 11 December 2014 | Final date for Comment: 09 February 2015

<p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to allow the nonprescription use of Mometasone furoate monohydrate for the conditions listed below. Only the human part of the PDL is proposed to be revised. The proposed wording of the new listing is:</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">Drugs containing the following: Adrenocortical hormones or their salts or derivatives</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">Including (but not limited to): Hydrocortisone, Hydrocortisone acetate, Hydrocortisone valerate, Hydrocortisone sodium succinate, Clobetasone butyrate, Difluprednate and Mometasone furoate monohydrate</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">Qualifier: Mometasone furoate monohydrate for the treatment of allergic rhinitis in a nasal spray that delivers 50 micrograms (mcg)/spray for those 12 years of age and older.</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-family:Verdana, sans-serif;font-size:9.5pt;">If all comments not in favour of this change can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL.</span></span><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;"></span></span></p>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)

Regulation Type: Regular notification

Human health

Notice of Consultation- Prescription Drug List (PDL): Mometasone Furoate Monohydrate (2 pages, in English and French)

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Distribution date: 11 December 2014 | Final date for Comment: 09 February 2015

<p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to allow the nonprescription use of Mometasone furoate monohydrate for the conditions listed below. Only the human part of the PDL is proposed to be revised. The proposed wording of the new listing is:</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">Drugs containing the following: Adrenocortical hormones or their salts or derivatives</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">Including (but not limited to): Hydrocortisone, Hydrocortisone acetate, Hydrocortisone valerate, Hydrocortisone sodium succinate, Clobetasone butyrate, Difluprednate and Mometasone furoate monohydrate</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">Qualifier: Mometasone furoate monohydrate for the treatment of allergic rhinitis in a nasal spray that delivers 50 micrograms (mcg)/spray for those 12 years of age and older.</span></span></p><p align="left"><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-family:Verdana, sans-serif;font-size:9.5pt;">If all comments not in favour of this change can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL.</span></span><span style="color:black;font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;"></span></span></p>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)

Regulation Type: Regular notification

Human health

Letter of the Federal Service for the Veterinary and Phytosanitary Surveillance No. FS-NV-8/23783 as of 1 December 2014

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Distribution date: 10 December 2014

This letter introduces a temporary restriction on imports of poultry meat and all poultry products, not heat treated (at least 70°C), feeds and feed additives for poultry (except feed additives of chemical and microbiological synthesis), used equipment for keeping, slaughter and butchering of birds from Germany to the territory of the Russian Federation due to the outbreak of highly pathogenic avian influenza. Furthermore, it also introduces a temporary restriction on imports of live poultry, hatching eggs, feathers, poultry meat and all poultry products, not heat treated (at least 70°C), feeds and feed additives for poultry, used equipment for keeping, slaughter and butchering of birds from Mecklenburg-Western Pomerania and Brandenburg (Germany) to the territory of the Russian Federation due to the above-mentioned reason. As for deliveries of the live poultry, hatching eggs from Germany to Russia, the appropriate veterinary certificates must be accompanied by an annex, signed and stamped by the veterinarian, who issued the veterinary certificate. The sample is attached to the letter.

Products Covered: Poultry meat and all poultry products, feeds and feed additives for poultry, used equipment for keeping, slaughter and butchering of birds, live poultry, hatching eggs, feathers.

Regulation Type: Emergency notifications (SPS)

Animal diseases Food safety Feed additives Zoonoses Animal feed Animal health Human health Pest- or Disease- free Regions / Regionalization Avian Influenza

Letter of the Federal Service for the Veterinary and Phytosanitary Surveillance No. FS-NV-8/23783 as of 1 December 2014

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Distribution date: 10 December 2014

This letter introduces a temporary restriction on imports of poultry meat and all poultry products, not heat treated (at least 70°C), feeds and feed additives for poultry (except feed additives of chemical and microbiological synthesis), used equipment for keeping, slaughter and butchering of birds from Germany to the territory of the Russian Federation due to the outbreak of highly pathogenic avian influenza. Furthermore, it also introduces a temporary restriction on imports of live poultry, hatching eggs, feathers, poultry meat and all poultry products, not heat treated (at least 70°C), feeds and feed additives for poultry, used equipment for keeping, slaughter and butchering of birds from Mecklenburg-Western Pomerania and Brandenburg (Germany) to the territory of the Russian Federation due to the above-mentioned reason. As for deliveries of the live poultry, hatching eggs from Germany to Russia, the appropriate veterinary certificates must be accompanied by an annex, signed and stamped by the veterinarian, who issued the veterinary certificate. The sample is attached to the letter.

Products Covered: Poultry meat and all poultry products, feeds and feed additives for poultry, used equipment for keeping, slaughter and butchering of birds, live poultry, hatching eggs, feathers.

Regulation Type: Emergency notifications (SPS)

Animal diseases Food safety Feed additives Zoonoses Animal feed Animal health Human health Pest- or Disease- free Regions / Regionalization Avian Influenza

Proyecto de reglamento de servicios privados de control de plagas (Draft Regulation on private pest control services)

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Distribution date: 05 December 2014 | Final date for Comment: 03 February 2015

The notified draft Regulation establishes the technical, logistical and sanitary requirements to be met by the operators, establishments and staff engaged in the provision of private pest control services, including phytosanitary treatment application services and structural pest control services.

Products Covered: Private pest control services

Regulation Type: Regular notification

Human health Pesticides Plant health Territory protection

Proyecto de reglamento de servicios privados de control de plagas (Draft Regulation on private pest control services)

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Distribution date: 05 December 2014 | Final date for Comment: 03 February 2015

The notified draft Regulation establishes the technical, logistical and sanitary requirements to be met by the operators, establishments and staff engaged in the provision of private pest control services, including phytosanitary treatment application services and structural pest control services.

Products Covered: Private pest control services

Regulation Type: Regular notification

Human health Pesticides Plant health Territory protection

The Kingdom of Saudi Arabia/The Cooperation Council for the Arab States of the Gulf Draft Technical Regulation for: "Tea and herbs bags".

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Distribution date: 03 December 2014 | Final date for Comment: 01 February 2015

This draft technical regulation applies to requirements (physical, chemical, microbiological, radiological) for different types of tea and herbs bags, sampling, methods of examination and tests.

Products Covered: Tea and herbs bags, (ICS Code: 67.250).

Regulation Type: Regular notification

Human health Contaminants Food safety Packaging

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