Regulatory Updates
<p><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">Notice of Intent to Amend the Prescription Drug List (PDL): Naloxone</span></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The proposed amendment notified in G/TBT/N/CAN/474 (dated 14 January 2016) was adopted 22 March 2016. </span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The purpose of this Notice of Amendment is to notify that as a result of consultation Health Canada has revised the listing for naloxone on the Prescription Drug List (PDL). Health Canada has conducted a scientific review of naloxone against a set of established and publicly available criteria 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 14 January 2016 Notice of Consultation.</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-naloxone-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-naloxone-eng.php</a></span><span lang="EN-GB"> (English)</span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-naloxone-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-naloxone-fra.php</a> (French)</span></span><br /></p><p><span style="line-height:13.5pt;font-family:Verdana, sans-serif;font-size:9pt;">Or requested from:</span></p><p>Canada's SPS & TBT Notification Authority and Enquiry Point<br />Global Affairs Canada <br />Technical Barriers and Regulations Division (TPB) <br />111 Sussex Drive, Ottawa, ON K1A 0G2 <br />Canada <br />Telephone: (343)203-4273<br />Fax: (613)943-0346<br />E-mail: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a><span style="line-height:13.5pt;font-family:Verdana, sans-serif;font-size:9pt;"> </span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span></span></p>
Distribution date: 30 March 2016
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Diethofencarb.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.01) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06 and 12.07)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Tepraloxydim.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Tepraloxydim.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Bendiocarb.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.06, 02.07 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.09 and 07.10) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.03 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Bendiocarb.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.06, 02.07 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.09 and 07.10) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.03 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Acetochlor.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.03, 07.08, 07.09 and 07.10) - Cereals (HS Codes: 10.01, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Acetochlor.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.03, 07.08, 07.09 and 07.10) - Cereals (HS Codes: 10.01, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.01)
Regulation Type: Regular notification
SI 5438 part 4 - Chemicals used for treatment of water intended for human consumption: Fluorosilicic acid (Hexafluorosilicic acid) (22 pages, in English; 8 pages, in Hebrew)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 4, dealing with f</span></span></span>luorosilicic acid (Hexafluorosilicic acid) used as a<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span> c</span></span></span>hemical for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 12175: May 2013 </span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-language:EN-GB;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ansi-language:EN-GB;mso-bidi-language:AR-SA;">and changes the packaging, labelling, marking, storing and transporting requirements to comply with Israel Mandatory Standards SI 2302 parts 1 and 2 instead of the European legislation.</span></span><span lang="EN-GB"><span style="letter-spacing:-0.1pt;"> </span></span></p>
Products Covered: Chemicals for purification of water - Fluorosilicic acid (Hexafluorosilicic acid)
Regulation Type: Regular notification
SI 5438 part 4 - Chemicals used for treatment of water intended for human consumption: Fluorosilicic acid (Hexafluorosilicic acid) (22 pages, in English; 8 pages, in Hebrew)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 4, dealing with f</span></span></span>luorosilicic acid (Hexafluorosilicic acid) used as a<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span> c</span></span></span>hemical for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 12175: May 2013 </span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-language:EN-GB;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ansi-language:EN-GB;mso-bidi-language:AR-SA;">and changes the packaging, labelling, marking, storing and transporting requirements to comply with Israel Mandatory Standards SI 2302 parts 1 and 2 instead of the European legislation.</span></span><span lang="EN-GB"><span style="letter-spacing:-0.1pt;"> </span></span></p>
Products Covered: Chemicals for purification of water - Fluorosilicic acid (Hexafluorosilicic acid)
Regulation Type: Regular notification
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