Regulatory Updates

Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses to Enable the Use of Powdered Cellulose as a Bulking Agent in Dry Mixes for Sweet Baked Goods

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Distribution date: 11 August 2014 | Final date for Comment: 14 October 2014

Health Canada's Food Directorate completed a detailed safety assessment of the use of powdered cellulose as a bulking agent in dry mixes for sweet baked goods. Cellulose powdered is already permitted for use in Canada as a bulking agent in various foods, including sweet baked goods. As no safety concerns were raised through this assessment, the Department has enabled the food additive use described in the information document by the List of Permitted Food Additives with Other Generally Accepted Uses (http://www.hc-sc.gc.ca/fn-an/securit/addit/list/8-other-autre-eng.php), effective 1 August 2014. 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. Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in use of any food additive, including cellulose. Anyone wishing to submit new scientific information on the use of this additive or to submit any inquiries may do so in writing, by regular mail or electronically.

Products Covered: Powdered cellulose (ICS Codes: 67.220, 67.060)

Regulation Type: Regular notification

Food safety Human health Food additives

2nd Call for Submissions for Proposal P1022 Primary Production and Processing Requirements for Raw Milk Products

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Distribution date: 08 August 2014 | Final date for Comment: 18 September 2014

Proposal P1022 has been prepared to assess additional requirements for milk production, transport and processing for the safe production of raw milk products, where it can be demonstrated that the intrinsic physico-chemical characteristics of the raw milk product do not support the growth of pathogens, and there is no net increase in pathogen levels during processing. FSANZ is consulting on draft variations to Standards 4.2.4 Primary Production and Processing Standard for Dairy Products, 4.2.4A Primary Production and Processing Standard for Specific Cheeses and 1.6.1 Microbiological Limits. FSANZ has extended the final date for comments to 18 September 2014.

Products Covered:

Regulation Type: Addendum to Regular Notification

Modification of final date for comments

2nd Call for Submissions for Proposal P1022 Primary Production and Processing Requirements for Raw Milk Products

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Distribution date: 08 August 2014 | Final date for Comment: 18 September 2014

Proposal P1022 has been prepared to assess additional requirements for milk production, transport and processing for the safe production of raw milk products, where it can be demonstrated that the intrinsic physico-chemical characteristics of the raw milk product do not support the growth of pathogens, and there is no net increase in pathogen levels during processing. FSANZ is consulting on draft variations to Standards 4.2.4 Primary Production and Processing Standard for Dairy Products, 4.2.4A Primary Production and Processing Standard for Specific Cheeses and 1.6.1 Microbiological Limits. FSANZ has extended the final date for comments to 18 September 2014.

Products Covered:

Regulation Type: Addendum to Regular Notification

Modification of final date for comments

National Food Safety Standard: Food additive Propane

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Distribution date: 04 August 2014 | Final date for Comment: 03 October 2014

The standard applied to the food additive propane that is distilled, absorbed in oil or frozen from natural gas.

Products Covered: Food additive Propane

Regulation Type: Regular notification

Food safety Human health Food additives

National Food Safety Standard: Food additive Propane

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Distribution date: 04 August 2014 | Final date for Comment: 03 October 2014

The standard applied to the food additive propane that is distilled, absorbed in oil or frozen from natural gas.

Products Covered: Food additive Propane

Regulation Type: Regular notification

Food safety Human health Food additives

; ;By means of this Addendum No. 2, the Republic of Ecuador advises that Amendment No. 2 to Emergency Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 088: "Surface tension agents", notified in document G/TBT/N/ECU/117 of 22 November 2013, has been issued pursuant to Resolution No. 14 262 of 26 June 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in the Supplement to Official Journal No. 299 of 29 July 2014. ;Text available from: ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ;Contact person: Marlon Martínez B. ;Yánez Pinzón N26-12, entre Av. Colón y La Niña ;Quito, Ecuador ;Tel.: (+593) 2 394-8760, Ext. 2358/2255 ;Email: [email protected]; [email protected] ; ;

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Distribution date: 01 August 2014

Products Covered: 34.01.11.00, 34.01.19.00, 34.01.19.10, 34.01.19.90, 34.01.20.00, 34.01.30.00, 34.02.11.10, 34.02.11.90, 34.02.12.10, 34.02.12.90, 34.02.13.10, 34.02.13.90, 34.02.19.10, 34.02.19.90, 34.02.20.00, and 34.05.40.00. ;

Regulation Type: Addendum to Regular Notification

; ;By means of this Addendum No. 2, the Republic of Ecuador advises that Amendment No. 2 to Emergency Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 088: "Surface tension agents", notified in document G/TBT/N/ECU/117 of 22 November 2013, has been issued pursuant to Resolution No. 14 262 of 26 June 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in the Supplement to Official Journal No. 299 of 29 July 2014. ;Text available from: ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ;Contact person: Marlon Martínez B. ;Yánez Pinzón N26-12, entre Av. Colón y La Niña ;Quito, Ecuador ;Tel.: (+593) 2 394-8760, Ext. 2358/2255 ;Email: [email protected]; [email protected] ; ;

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Distribution date: 01 August 2014

Products Covered: 34.01.11.00, 34.01.19.00, 34.01.19.10, 34.01.19.90, 34.01.20.00, 34.01.30.00, 34.02.11.10, 34.02.11.90, 34.02.12.10, 34.02.12.90, 34.02.13.10, 34.02.13.90, 34.02.19.10, 34.02.19.90, 34.02.20.00, and 34.05.40.00. ;

Regulation Type: Addendum to Regular Notification

2nd Call for Submissions for Proposal P1022 - Primary Production & Processing Requirements for Raw Milk Products

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Distribution date: 18 July 2014 | Final date for Comment: 29 August 2014

Proposal P1022 has been prepared to assess additional requirements for milk production, transport and processing for the safe production of raw milk products, where it can be demonstrated that the intrinsic physico-chemical characteristics of the raw milk product do not support the growth of pathogens, and there is no net increase in pathogen levels during processing. FSANZ is consulting on draft variations to Standards 4.2.4 - Primary Production and Processing Standard for Dairy Products, 4.2.4A - Primary Production and Processing Standard for Specific Cheeses and 1.6.1- Microbiological Limits. All proposals to change the Australia New Zealand Food Standards Code, must be assessed in the context of the following objectives: (a) the protection of public health and safety; (b) the provision of adequate information relating to food to enable consumers to make informed choices; and (c) the prevention of misleading or deceptive conduct.

Products Covered: Raw milk products sold in Australia (both imported and domestically produced) where it can be demonstrated: - that the intrinsic physico-chemical characteristics of the raw milk product do not support the growth of pathogens, and - there is no net increase in pathogen levels during processing. Raw milk products are dairy products made with raw milk, but do not include milk.

Regulation Type: Regular notification

Food safety Labelling Human health Bacteria

2nd Call for Submissions for Proposal P1022 - Primary Production & Processing Requirements for Raw Milk Products

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Distribution date: 18 July 2014 | Final date for Comment: 29 August 2014

Proposal P1022 has been prepared to assess additional requirements for milk production, transport and processing for the safe production of raw milk products, where it can be demonstrated that the intrinsic physico-chemical characteristics of the raw milk product do not support the growth of pathogens, and there is no net increase in pathogen levels during processing. FSANZ is consulting on draft variations to Standards 4.2.4 - Primary Production and Processing Standard for Dairy Products, 4.2.4A - Primary Production and Processing Standard for Specific Cheeses and 1.6.1- Microbiological Limits. All proposals to change the Australia New Zealand Food Standards Code, must be assessed in the context of the following objectives: (a) the protection of public health and safety; (b) the provision of adequate information relating to food to enable consumers to make informed choices; and (c) the prevention of misleading or deceptive conduct.

Products Covered: Raw milk products sold in Australia (both imported and domestically produced) where it can be demonstrated: - that the intrinsic physico-chemical characteristics of the raw milk product do not support the growth of pathogens, and - there is no net increase in pathogen levels during processing. Raw milk products are dairy products made with raw milk, but do not include milk.

Regulation Type: Regular notification

Food safety Labelling Human health Bacteria

<p><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Notice of Intent to Amend the Prescription Drug List (PDL): Triamcinolone acetonide</span></span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The proposed amendment notified in G/TBT/N/CAN/411 (dated 28 March 2014) was adopted 14 July&nbsp;2014.</span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to exempt Triamcinolone acetonide. Health Canada has conducted a scientific review of Triamcinolone acetonide against the set of established and publicly available criteria </span></span><span lang="EN-GB">outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording remains unchanged from what was proposed in the Notice of Consultation.<em><span style="color:#00b050;"></span></em></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">This revision will be in effect six months from the date of this Notice</span></span><span lang="EN-GB">&nbsp;posted on the Health Canada website.</span></p><p align="left"><span style="color:#00b050;font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">&nbsp;</span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The full text of the adopted measure can be downloaded from the Internet addresses indicated below:<span style="color:#00b050;"> </span></span></span></p><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_triamcinolone_acetonide-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_triamcinolone_acetonide-eng.php</a> (English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_triamcinolone_acetonide-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_triamcinolone_acetonide-fra.php</a> (French)<p></p><p>or requested from:</p><p>Canada’s SPS &amp; TBT Notification Authority and Enquiry Point<br />Foreign Affairs, Trade and Development Canada<br />Technical Barriers and Regulations Division (TIB)<br />111 Sussex Drive<br />Ottawa, ON&nbsp; K1A 0G2<br />Canada<br />Telephone:&nbsp; (343)203-4273<br />Fax: (613)943-0346<br />E-mail: <a href="mailto:[email protected]">[email protected]</a></p><p><span lang="EN-GB"></span><span style="color:black;font-size:small;font-face:Helv;"></span></p>

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Distribution date: 17 July 2014

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

Regulation Type: Addendum to Regular Notification

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