Regulatory Updates

Interim Marketing Authorization regarding the continued use of caffeine and caffeine citrate as food additives in non-alcoholic carbonated water-based flavoured and sweetened beverages other than cola-type beverages

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Distribution date: 05 April 2012

Notice is hereby given that Health Canada has received a request to continue to permit the use of caffeine and caffeine citrate as food additives in non-alcoholic carbonated water-based flavoured and sweetened beverages other than cola-type beverages, notified under G/SPS/N/CAN/439. The maximum level of use of caffeine and caffeine citrate (calculated as caffeine), used singly or in combination in these beverages, would be 150 ppm in the finished product. This authorization is intended to provide for the continued addition of caffeine and caffeine citrate to the beverages commonly referred to as carbonated soft drinks, other than cola-type soft drinks. This authorization does not change the provisions for the use of caffeine and caffeine citrate in cola-type beverages, which will continue to be permitted at a maximum level of use of 200 ppm in the finished product. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to continue to permit the use of caffeine and caffeine citrate, as indicated above, while the regulatory process to amend the Regulations continues.

Products Covered:

Regulation Type: Addendum to Regular Notification

Food additives Human health Food safety

Interim Marketing Authorization regarding the continued use of caffeine and caffeine citrate as food additives in non-alcoholic carbonated water-based flavoured and sweetened beverages other than cola-type beverages

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Distribution date: 05 April 2012

Notice is hereby given that Health Canada has received a request to continue to permit the use of caffeine and caffeine citrate as food additives in non-alcoholic carbonated water-based flavoured and sweetened beverages other than cola-type beverages, notified under G/SPS/N/CAN/439. The maximum level of use of caffeine and caffeine citrate (calculated as caffeine), used singly or in combination in these beverages, would be 150 ppm in the finished product. This authorization is intended to provide for the continued addition of caffeine and caffeine citrate to the beverages commonly referred to as carbonated soft drinks, other than cola-type soft drinks. This authorization does not change the provisions for the use of caffeine and caffeine citrate in cola-type beverages, which will continue to be permitted at a maximum level of use of 200 ppm in the finished product. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to continue to permit the use of caffeine and caffeine citrate, as indicated above, while the regulatory process to amend the Regulations continues.

Products Covered:

Regulation Type: Addendum to Regular Notification

Food additives Human health Food safety

Partial amendment to the Minimum Requirements for Biological Products (1 page, available in English)

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Distribution date: 04 April 2012 | Final date for Comment: 27 April 2012

The Minimum Requirements for Biological Products shall be partially amended to add the standard for a vaccine to be newly approved.

Products Covered: Drugs (HS: 30)

Regulation Type: Regular notification

Human health

Partial amendment to the Minimum Requirements for Biological Products (1 page, available in English)

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Distribution date: 04 April 2012 | Final date for Comment: 27 April 2012

The Minimum Requirements for Biological Products shall be partially amended to add the standard for a vaccine to be newly approved.

Products Covered: Drugs (HS: 30)

Regulation Type: Regular notification

Human health

Draft Amendment of the Official Standards for Ordinary Fertilizers ( 12 pages, in English)

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Distribution date: 04 April 2012 | Final date for Comment: 03 June 2012

Official standard to be amended: ; EFused silicate phosphate ; EMixed organic fertilizer ; EComplex fertilizer ; EMixed sludge compound fertilizer ; ; Official standards to be established: ; EFused sludge ash silicate phosphate fertilizer ; EMixed animal waste compound fertilizer ; EMixed compost compound fertilizer ; EMixed fertilizer that contains agricultural chemicals ;

Products Covered: Fertilizer (HS: 3101, ; 3103,3105) ;

Regulation Type: Regular notification

Plant health

Draft Amendment of the Official Standards for Ordinary Fertilizers ( 12 pages, in English)

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Distribution date: 04 April 2012 | Final date for Comment: 03 June 2012

Official standard to be amended: ; EFused silicate phosphate ; EMixed organic fertilizer ; EComplex fertilizer ; EMixed sludge compound fertilizer ; ; Official standards to be established: ; EFused sludge ash silicate phosphate fertilizer ; EMixed animal waste compound fertilizer ; EMixed compost compound fertilizer ; EMixed fertilizer that contains agricultural chemicals ;

Products Covered: Fertilizer (HS: 3101, ; 3103,3105) ;

Regulation Type: Regular notification

Plant health

This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro – National Institute of Metrology, Quality, and Technology previously notified under G/TBT/N/BRA/375/Add.1 (school items) as Ministerial Act n º 481, 7 December 2010 was amended by Inmetro Ordinance Ministerial Act n º 90, 23 February 2012, incorporating changes of some items and revoking articles. ; ; Additionally, incorporates the provisions under item 6.2 of the Inmetro Ordinance Ministerial Act n º 491/2010, concerning the registration’s renewal documents as part of the conformity assessment procedures and revokes Ministerial Act nº 188, 8 June 2007, to the stated date of 23 December 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001796.pdf ;

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Distribution date: 27 March 2012

Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.

Regulation Type: Addendum to Regular Notification

This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro – National Institute of Metrology, Quality, and Technology previously notified under G/TBT/N/BRA/375/Add.1 (school items) as Ministerial Act n º 481, 7 December 2010 was amended by Inmetro Ordinance Ministerial Act n º 90, 23 February 2012, incorporating changes of some items and revoking articles. ; ; Additionally, incorporates the provisions under item 6.2 of the Inmetro Ordinance Ministerial Act n º 491/2010, concerning the registration’s renewal documents as part of the conformity assessment procedures and revokes Ministerial Act nº 188, 8 June 2007, to the stated date of 23 December 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001796.pdf ;

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Distribution date: 27 March 2012

Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.

Regulation Type: Addendum to Regular Notification

Regulations Amending the Food and Drug Regulations (1611 - Asparaginase)

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Distribution date: 23 March 2012

The proposed amendments notified in G/SPS/N/CAN/403 (dated 15 December 2009) were adopted 2 March 2012 as the Regulations Amending the Food and Drug Regulations (1611 - Asparaginase). These Regulations entered into force on 2 March 2012.

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Regulations Amending the Food and Drug Regulations (1611 - Asparaginase)

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Distribution date: 23 March 2012

The proposed amendments notified in G/SPS/N/CAN/403 (dated 15 December 2009) were adopted 2 March 2012 as the Regulations Amending the Food and Drug Regulations (1611 - Asparaginase). These Regulations entered into force on 2 March 2012.

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

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