Regulatory Updates

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: 05 May 2014 | Final date for Comment: 04 July 2014

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

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.08, 07.09 and 07.10) - Cereals (HS Codes: 10.01, 10.03 and 10.05) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.06) - 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: 05 May 2014 | Final date for Comment: 04 July 2014

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

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.03, 07.04, 07.05, 07.06, 07.09 and 07.10) - 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)

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: 05 May 2014 | Final date for Comment: 04 July 2014

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

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.03, 07.04, 07.05, 07.06, 07.09 and 07.10) - 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)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Proyecto de Reglamento Técnico Ecuatoriano PRTE INEN 208, "Cocinas de uso comercial. Seguridad" (Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 208, "Commercial cookers. Safety") (6 pages, in Spanish) ;

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Distribution date: 22 April 2014 | Final date for Comment: 21 June 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Classification; Product requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

Products Covered: 8516.60.20 and 8516.60.30. ;

Regulation Type: Regular notification

Proyecto de Reglamento Técnico Ecuatoriano PRTE INEN 208, "Cocinas de uso comercial. Seguridad" (Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 208, "Commercial cookers. Safety") (6 pages, in Spanish) ;

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Distribution date: 22 April 2014 | Final date for Comment: 21 June 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Classification; Product requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

Products Covered: 8516.60.20 and 8516.60.30. ;

Regulation Type: Regular notification

Draft Amendment of the Official Standards for Ordinary Fertilizers, etc. (2 pages, in English).

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Distribution date: 22 April 2014 | Final date for Comment: 21 June 2014

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana', 'sans-serif';font-size:9pt;">In order to make </span><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="color:black;font-size:9pt;">parts of cattle</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">able to be used as a fertilizer</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"><span style="color:black;"><span style="color:black;">or an ingredient of fertilizers, </span></span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">the </span><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="color:black;font-size:9pt;">new</span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">requirements</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">which are equivalent to<span style="color:black;"><span style="color:black;">those for bovine Flesh-Bone Meal,</span></span> </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">are to be established</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">.</span></span></span></span></span></span></span></span></span></span>

Products Covered: Fertilizer (HS: 3101, 3103, 3105) or vegetable fertilizers, whether or not mixed together or chemically treated; fertilizers produced by the mixing or chemical treatment of animal or vegetable products. (HS 3101), Mineral or chemical fertilizers, phosphatic - HS 3103, Mineral or chemical fertilizers containing two or three of the fertilizing elements nitrogen, phosphorus and potassium; other fertilizers; goods of this Chapter in tablets or similar forms or in packages of a gross weight not exceeding 10 kg HS 3105.

Regulation Type: Regular notification

Draft Amendment of the Official Standards for Ordinary Fertilizers, etc. (2 pages, in English).

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Distribution date: 22 April 2014 | Final date for Comment: 21 June 2014

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana', 'sans-serif';font-size:9pt;">In order to make </span><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="color:black;font-size:9pt;">parts of cattle</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">able to be used as a fertilizer</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"><span style="color:black;"><span style="color:black;">or an ingredient of fertilizers, </span></span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">the </span><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="color:black;font-size:9pt;">new</span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">requirements</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">which are equivalent to<span style="color:black;"><span style="color:black;">those for bovine Flesh-Bone Meal,</span></span> </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">are to be established</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">.</span></span></span></span></span></span></span></span></span></span>

Products Covered: Fertilizer (HS: 3101, 3103, 3105) or vegetable fertilizers, whether or not mixed together or chemically treated; fertilizers produced by the mixing or chemical treatment of animal or vegetable products. (HS 3101), Mineral or chemical fertilizers, phosphatic - HS 3103, Mineral or chemical fertilizers containing two or three of the fertilizing elements nitrogen, phosphorus and potassium; other fertilizers; goods of this Chapter in tablets or similar forms or in packages of a gross weight not exceeding 10 kg HS 3105.

Regulation Type: Regular notification

Partial amendment to the Minimum Requirements for Biological Products. (1 pages, in English).

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Distribution date: 16 April 2014 | Final date for Comment: 15 June 2014

<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 a </span><span style="font-size:x-small;"><span style="font-size:x-small;"><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)

Regulation Type: Regular notification

Human health

Partial amendment to the Minimum Requirements for Biological Products. (1 pages, in English).

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Distribution date: 16 April 2014 | Final date for Comment: 15 June 2014

<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 a </span><span style="font-size:x-small;"><span style="font-size:x-small;"><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)

Regulation Type: Regular notification

Human health

Administrative Regulation on fulfilment by the Federal Service for Veterinary and Phytosanitary Supervision of function on carrying out control over compliance with the legislation of the Russian Federation in the sphere of veterinary at the state border of the Russian Federation (including points of entry across the state border) and on transport, including requirements for ensuring security of the territory of the Russian Federation against introduction from foreign countries and spread of contagious animal diseases, import of dangerous veterinary-sanitary under control consignments

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Distribution date: 11 April 2014 | Final date for Comment: 10 June 2014

This document establishes deadlines and a sequence of administrative procedures (actions) by the Federal Service for Veterinary and Phytosanitary Supervision and its territorial offices, as well as by customs services exercising veterinary state supervision at the state border of the Russian Federation. The proposed Regulation sets procedures for cooperation between units and officials of the above mentioned authorities, cooperation with legal and natural persons, other governmental authorities and institutions of local government, establishments and organizations in the import, export and transit of controlled goods.

Products Covered: Common list of goods subject to veterinary control (supervision), adopted by the Customs Union (CU) Commission Decision "On application of veterinary and sanitary measures in the CU" No. 317 as of 18 June 2010

Regulation Type: Regular notification

Animal health Human health Certification, control and inspection Food safety

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