<p><span style="text-decoration:underline;">Notice of Intent to Amend the Prescription Drug List (PDL): Hyoscine butylbromide</span><br /><br />The proposed amendment notified in G/TBT/N/CAN/471 (dated 29 October 2015) was adopted on&nbsp;12 February 2016.<br /><br />The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch injectable Hyoscine butylbromide to prescription status from ethical status for human use by adding it to the Human Prescription Drug List (PDL). Injectable Hyoscine butylbromide is already listed on the Veterinary Prescription Drug List. Health Canada has conducted a scientific review of Hyoscine butylbromide against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording has not changed from what was proposed in the 16 October 2015 Notice of Consultation.<br />This revision will be in effect six months from the date of this Notice posted on the Health Canada website.<br /><br />The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</p><p><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-hyoscine-butylbromide-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-hyoscine-butylbromide-eng.php</a> &nbsp;(English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-hyoscine-butylbromide-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-hyoscine-butylbromide-fra.php</a> &nbsp;(French)<br /></p><p>or requested from:</p>Canada's SPS &amp; 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:[email protected]">[email protected]</a><br />

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Distribution date: 17 February 2016 | Final date for Comment: 04 May 2025

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)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed designation of a substance used as an ingredient of agricultural chemicals and other chemical substances that is stipulated to be "Not detected" in foods for the following agricultural chemical: Veterinary drug : Ipronidazole.

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) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - 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: 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10 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 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, 12.05 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Food safety Maximum residue limits (MRLs) Veterinary drugs

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed designation of a substance used as an ingredient of agricultural chemicals and other chemical substances that is stipulated to be "Not detected" in foods for the following agricultural chemical: Veterinary drug : Ipronidazole.

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) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - 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: 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10 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 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, 12.05 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Food safety Maximum residue limits (MRLs) Veterinary drugs

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug : Tulathromycin.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03 and 02.06) - Products of animal origin (HS Code: 05.04)

Regulation Type: Regular notification

Human health Veterinary drugs Maximum residue limits (MRLs) Food safety

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug : Tulathromycin.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03 and 02.06) - Products of animal origin (HS Code: 05.04)

Regulation Type: Regular notification

Human health Veterinary drugs Maximum residue limits (MRLs) Food safety

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Chlorobenzilate.

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: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.05) - 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)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Chlorobenzilate.

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: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.05) - 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)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Dinoseb.

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: 09.02, 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)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Dinoseb.

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: 09.02, 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)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 18 February 2016 | Final date for Comment: 18 April 2016

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Thifensulfuron.

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: 07.09, 07.10 and 07.13) - Edible fruits and nuts, peel of citrus/melons (HS Code: 08.14) - Coffee, tea, mate and spices (HS Codes: 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, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.07 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Pesticides Maximum residue limits (MRLs) Food safety

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