Regulatory Updates
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 27 February 2015 | Final date for Comment: 28 April 2015
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug - Meloxicam
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - Dairy produce, birds' eggs and natural honey (HS Code: 04.01) - Products of animal origin (HS Code: 05.04) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
<p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">This addendum aims at informing that the Ministry of Agriculture, Livestock and Food Supply, issued Ordinance Nº</span></span><span lang="EN-US"> 03, 26 January 2015 (Instrução Normativa Nº 03, de 26 de Janeiro de 2015), </span><span lang="EN-GB">published in the </span><span lang="EN-US">Brazilian Official </span><span lang="EN-GB">Gazette N°</span><span lang="EN-GB">18, 27 January 2015, section 1, page 12</span><span lang="EN-US">, to approve the official methods for testing samples of fertilizers control,</span><span lang="EN-US"> </span><span lang="EN-US">based on the provisions in Decree Nº 8384, 29 December 2014, notified under the document </span><span><span lang="EN-GB" style="background:white;">G/TBT/N/BRA/563/Add.1.</span></span></p><p><span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="background:white;font-size:9pt;"><span>This Ordinance (Nº 3/2015) revokes Ordinance Nº 28, 27 July 2007 (Instrução Normativa SDA Nº 28, 27 July 2007). </span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The full text of this measure is available in Portuguese and can be downloaded at: </span></span>http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=27/01/2015&jornal=1&pagina=12&totalArquivos=56</p>
Distribution date: 26 February 2015
Products Covered: Fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials (HS 31)
Regulation Type: Addendum to Regular Notification
Partial amendment to the Minimum Requirements for Biological Products (1 pages, in English)
Distribution date: 26 February 2015 | Final date for Comment: 20 March 2015
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">The Minimum Requirements for Biological Products </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">is to</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">be partially amended to add the standard for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">a</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">vaccine product</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">to be newly approved.</span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 pages, in English)
Distribution date: 26 February 2015 | Final date for Comment: 20 March 2015
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">The Minimum Requirements for Biological Products shall be partially amended to revise the standard for the "I</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">nfluenza </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">HA V</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">accine"</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">.</span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
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: 26 February 2015 | Final date for Comment: 27 April 2015
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Kresoxim-methyl
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 Code: 04.01) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 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, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
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: 03 February 2015 | Final date for Comment: 04 April 2015
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Fluoroimide
Products Covered: - 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) - 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: 03 February 2015 | Final date for Comment: 04 April 2015
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Fluoroimide
Products Covered: - 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) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
<p>La República de Ecuador da a conocer el Addendum No. 1 referente al Reglamento Técnico RTE INEN 229 "Artículos para fuegos artificiales", notificado mediante el documento identificado con la signatura G/TBT/N/ECU/260 del 23 de junio de 2014. Éste Addendum No. 1 ha sido expedido mediante la Resolución N° 15 024 del 26 de enero de 2015, emitida por la Subsecretaría de la Calidad del Ministerio de Industrias y Productividad, publicada en el Registro Oficial Nº 439 de lunes 18 de febrero de 2015.</p><p>Texto disponible en el Ministerio de Industrias y Productividad, Subsecretaría de la Calidad, Organismo Nacional encargado de la Notificación:</p><p>Responsable:Marlon Martínez B.<br />Yánez Pinzón No. 26-12 y Av. Colón. Edf. Rigel<br />Quito - Ecuador<br />Telf.: (+593-2) 3948760, Ext.2358 / 2255<br />Punto de Contacto: <a href="mailto:PuntocontactoOTCECU@mipro.gob.ec">PuntocontactoOTCECU@mipro.gob.ec</a> / <a href="mailto:mmartinez@mipro.gob.ec">mmartinez@mipro.gob.ec</a></p><p></p>
Distribution date: 24 February 2015
Products Covered: 3604.10.00 and 3604.90.00 ;
Regulation Type: Addendum to Regular Notification
Notification of the Ministry of Commerce Regarding Volatile Alkyl Nitrate Substance to Require Import Permit for Importation into the Kingdom of Thailand B.E. 2557(2014) (2 pages, in Thai)
Distribution date: 23 February 2015
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="font-family:'Verdana','sans-serif';font-size:9pt;">Volatile alkyl nitrate substance 6 items (Amyl nitrate, c</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">yclohexyl nitrite</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">, e</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">thyl nitrite</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">, i</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">sobutyl nitrite</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">, i</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">sopropyl nitrite and n-butyl nitrite) are required import permit.</span></span></span></span></span></span></span></span></span>
Products Covered: Volatile alkyl nitrate (HS: 2920.90.90, ICS: 71)
Regulation Type: Regular notification
<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): Mometasone furoate</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/435 (dated 11 December 2014) was adopted on 9 February 2015.</span></span></p><p><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 </span></span><span lang="EN-GB">Mometasone furoate. Health Canada has conducted a scientific review of Mometasone furoate against the set of established and publicly available criteria outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording <span style="text-decoration:underline;">has changed</span> from what was proposed in the 27 November 2014 Notice of Consultation.<em></em></span></p><p><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">through a Notice of Amendment posted on the Health Canada website.</span></p><p align="left"><span style="font-family:Verdana, sans-serif;">The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</span></p><p><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-size:9pt;"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_mometasone-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_mometasone-eng.php</a> </span></span><span lang="EN-GB">(English)</span><span style="color:black;"></span></p><p><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-size:9pt;"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_mometasone-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_mometasone-fra.php</a></span></span><span style="color:black;font-size:small;font-face:Helv;"><span style="font-family:Helv, sans-serif;font-size:10pt;"></span></span><span lang="EN-GB">(French)</span><span style="color:black;font-size:small;font-face:Helv;"></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">or requested from:</span></span></p><p>Canadas 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 K1A 0G2<br />Canada<br />Telephone: (343)203-4273<br />Fax: (613)943-0346<br />Email: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a></p><p align="left"></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"></span></span></p><br /><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"></span></span></p><p><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span></p>
Distribution date: 20 February 2015
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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