Regulatory Updates

Decreto Ejecutivo N°309 de 26 de diciembre de 2013 (Executive Decree No. 309 of 26 December 2013).

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Distribution date: 29 January 2014

The notified Executive Decree establishes that residue verification studies must be submitted when registering veterinary drugs containing ivermectin, doramectin, moxidectin or abamectin for use in bovine animals.

Products Covered: Antiparasitic agents for internal use (HS tariff subheading 3004.90.91)

Regulation Type: Regular notification

Food safety Feed additives Veterinary drugs Animal health Human health Animal feed

Letter of the State Sanitary Inspector No. 01/11491-13-23 as of 6 October 2013

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Distribution date: 27 January 2014

The Russian Federation notified the letter of the State Sanitary Inspector in G/SPS/N/RUS/35 (as of 11 October 2013). This letter introduced a temporary restriction on import of milk and milk products from Lithuania to the Russian Federation due to detection of incompliance to microbiology, sanitary chemical and organoleptic requirements. Lithuania provided relevant information on securing microbiological requirements, strengthening of production control, elimination of detected labeling deviations. Thus the measure was withdrawn with regard to import of milk and milk products from "Rokiskio suris" AB, Lithuania. At the moment the measure does not apply to milk and milk products from two Lithuanian establishments: "Pieno Zvaigzdes" and "Rokiskio suris" AB.

Products Covered:

Regulation Type: Addendum to Emergency Notification (SPS)

Modification of content/scope of regulation

Letter of the State Sanitary Inspector No. 01/11491-13-23 as of 6 October 2013

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Distribution date: 27 January 2014

The Russian Federation notified the letter of the State Sanitary Inspector in G/SPS/N/RUS/35 (as of 11 October 2013). This letter introduced a temporary restriction on import of milk and milk products from Lithuania to the Russian Federation due to detection of incompliance to microbiology, sanitary chemical and organoleptic requirements. Lithuania provided relevant information on securing microbiological requirements, strengthening of production control, elimination of detected labeling deviations. Thus the measure was withdrawn with regard to import of milk and milk products from "Rokiskio suris" AB, Lithuania. At the moment the measure does not apply to milk and milk products from two Lithuanian establishments: "Pieno Zvaigzdes" and "Rokiskio suris" AB.

Products Covered:

Regulation Type: Addendum to Emergency Notification (SPS)

Modification of content/scope of regulation

Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Asparaginase Obtained from Aspergillus niger AGN7-41 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized Foods

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Distribution date: 24 January 2014 | Final date for Comment: 06 April 2014

ealth Canada's Food Directorate completed a detailed safety assessment of asparaginase obtained from Aspergillus niger AGN7-41 as a food enzyme in bread, flour, whole wheat flour, and unstandardized foods. Asparaginase, when obtained from another strain of Aspergillus niger (A. niger ASP72), is already permitted for use in Canada as a food enzyme in bread, flour, whole wheat flour and unstandardized foods. As no safety concerns were raised through this assessment, the Department has enabled the food additive use described in the information document by updating the List of Permitted Food Enzymes, effective 21 January 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 asparaginase obtained from Aspergillus niger AGN7-41. 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: Asparaginase (ICS Codes: 67.060, 67.220)

Regulation Type: Regular notification

Food safety Human health Food additives

Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Asparaginase Obtained from Aspergillus niger AGN7-41 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized Foods

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Distribution date: 24 January 2014 | Final date for Comment: 06 April 2014

ealth Canada's Food Directorate completed a detailed safety assessment of asparaginase obtained from Aspergillus niger AGN7-41 as a food enzyme in bread, flour, whole wheat flour, and unstandardized foods. Asparaginase, when obtained from another strain of Aspergillus niger (A. niger ASP72), is already permitted for use in Canada as a food enzyme in bread, flour, whole wheat flour and unstandardized foods. As no safety concerns were raised through this assessment, the Department has enabled the food additive use described in the information document by updating the List of Permitted Food Enzymes, effective 21 January 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 asparaginase obtained from Aspergillus niger AGN7-41. 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: Asparaginase (ICS Codes: 67.060, 67.220)

Regulation Type: Regular notification

Food safety Human health Food additives

Ordinance Nº. 8, 10 January 2014: establishes, within the Brazilian System of Conformity Assessment - SBAC, the voluntary certification for Bottled Natural Mineral Water, which should be carried out by an accredited body, accredited by INMETRO and established in Brazil. (20 pages, in Portuguese).

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Distribution date: 23 January 2014 | Final date for Comment: 13 February 2014

<span style="font-face:Verdana;"><strong>Voluntary certification</strong></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana', 'sans-serif';font-size:9pt;">: proposed conformity assessment procedures for&nbsp;<span style="letter-spacing:-0.1pt;">Bottled Mineral Water,</span><span style="letter-spacing:-0.1pt;"> which should be carried out </span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">by an accredited body</span><span style="font-size:x-small;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">, established in Brazil,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">with a focus on food security.</span></span></span></span></span>

Products Covered: Waters, incl. natural or artificial mineral waters and aerated waters, not containing added sugar, other sweetening matter or flavoured; ice and snow (HS code(s): 2201)

Regulation Type: Regular notification

Food standards

Ordinance Nº. 8, 10 January 2014: establishes, within the Brazilian System of Conformity Assessment - SBAC, the voluntary certification for Bottled Natural Mineral Water, which should be carried out by an accredited body, accredited by INMETRO and established in Brazil. (20 pages, in Portuguese).

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Distribution date: 23 January 2014 | Final date for Comment: 13 February 2014

<span style="font-face:Verdana;"><strong>Voluntary certification</strong></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana', 'sans-serif';font-size:9pt;">: proposed conformity assessment procedures for&nbsp;<span style="letter-spacing:-0.1pt;">Bottled Mineral Water,</span><span style="letter-spacing:-0.1pt;"> which should be carried out </span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">by an accredited body</span><span style="font-size:x-small;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">, established in Brazil,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">with a focus on food security.</span></span></span></span></span>

Products Covered: Waters, incl. natural or artificial mineral waters and aerated waters, not containing added sugar, other sweetening matter or flavoured; ice and snow (HS code(s): 2201)

Regulation Type: Regular notification

Food standards

Regulation Regarding the Production, Import, Export and Marketing of Organic, Organomineral Fertilizers, Soil Improvers and the Products Containing Microbial, Enzyme and Other Products

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Distribution date: 21 January 2014 | Final date for Comment: 22 March 2014

This Regulation covers production, import, export and marketing of organic and organomineral fertilizers, soil improvers, and the products containing microbial, enzyme and other products.

Products Covered: Organic and organomineral fertilizers, soil improvers, and the products containing microbial, enzyme and other products

Regulation Type: Regular notification

Human health Food safety Plant health

Regulation Regarding the Production, Import, Export and Marketing of Organic, Organomineral Fertilizers, Soil Improvers and the Products Containing Microbial, Enzyme and Other Products

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Distribution date: 21 January 2014 | Final date for Comment: 22 March 2014

This Regulation covers production, import, export and marketing of organic and organomineral fertilizers, soil improvers, and the products containing microbial, enzyme and other products.

Products Covered: Organic and organomineral fertilizers, soil improvers, and the products containing microbial, enzyme and other products

Regulation Type: Regular notification

Human health Food safety Plant health

Amendments to the Enforcement Ordinance of the Standards of Feed and Feed Additives (Amendment of an agricultural chemical residue standard)

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Distribution date: 20 January 2014

Proposal for the establishment of the maximum residue limit (MRL) for an agricultural chemical (Pendimethaline). Commodity Proposed MRL (mg/kg) Current MRL (ppm) Hay 15 0.1 Note: Hay includes hay and fodder (dry), straw, forage (green) and silage. The MRL is set as 90% dry matter base.

Products Covered: Straw and forage of cereal grains and grasses, legume forage (alfalfa, clover, etc.) and other forage products (HS Codes: 12.13, 12.14) for feed

Regulation Type: Regular notification

Animal feed Animal health Human health Pest- or Disease- free Regions / Regionalization Pesticides Maximum residue limits (MRLs) Animal diseases Food safety

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