Regulatory Updates

Public Notification of Conformity Assessment for Broadcasting Communications Equipments (10 pages, in English)

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Distribution date: 06 February 2015 | Final date for Comment: 07 April 2015

<p style="margin-bottom:0pt;"><span style="font-size:x-small;font-face:Symbol;"><span style="font-family:Symbol;font-size:9pt;"><span>·<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="background:white;">Exclusion from conformity assessment for USB or Battery using the power products such as Digital scale, Thermo-hygrometer, thermometer, blood glucose meter, inclinometer, digital multimeters or similar equipments that have extremely short time of use and the markedly low potential hazard for simple calculations or measuring from the object. and &nbsp;USB and Battery using the power products will have been reclassified as items requiring for SDOC category <span style="letter-spacing:-0.1pt;">from designated testing laboratories;</span></span></p><p style="margin-bottom:0pt;"><span style="font-size:x-small;font-face:Symbol;"><span style="font-family:Symbol;font-size:9pt;"><span>·<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="background:white;">The test standards for USB and Battery using the power <span style="letter-spacing:-0.1pt;">products will have been changed to test methods (KN14-1, 14-2) from test methods (KN22, 24);</span></span></p><p style="margin-bottom:0pt;"><span style="font-size:x-small;font-face:Symbol;"><span style="font-family:Symbol;font-size:9pt;"><span>·<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="background:white;">Exclusion of items using auxiliary equipment of the products such as cable, cable connectors (gender, etc.), and cable accessories from the requirement for conformity assessment;</span></p><p style="margin-bottom:0pt;"><span style="font-size:x-small;font-face:Symbol;"><span style="font-family:Symbol;font-size:9pt;"><span>·<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="background:white;">Inclusion of lifts such as elevator for the requirement of conformity registration;</span></p><p style="margin-bottom:0pt;"><span style="font-size:x-small;font-face:Symbol;"><span style="font-family:Symbol;font-size:9pt;"><span>·<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="background:white;">Inclusion of Radio equipment using road information detection radar for the requirement of conformity certification;</span></p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="background:white;letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">Inclusion of Radio equipment using integrated public network for the requirement of conformity certification.</span></span>

Products Covered: Telecommunications equipments and electrical appliances

Regulation Type: Regular notification

Order of the Ministry of Agriculture of the Russian Federation as of 15 December 2014, No. 501

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Distribution date: 05 February 2015

This document adopts the list of quarantine pests for the Russian Federation.

Products Covered: List of the regulated products, adopted by Eurasian Economic Commission Decision as of 18 June 2010, No. 318

Regulation Type: Regular notification

Human health Pests Plant health

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: 03 February 2015 | Final date for Comment: 04 April 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Dichlobenil

Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.09 and 07.10) - 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: 09.04, 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: 12.04, 12.05, 12.06 and 12.07)

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: 27 February 2015 | Final date for Comment: 28 April 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Pyrifluquinazon

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 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 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, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.05)

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: 03 February 2015 | Final date for Comment: 04 April 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide/Veterinary drug - Teflubenzuron

Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Code: 03.07) - 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

Maximum residue limits (MRLs) Human health Pesticides 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: 03 February 2015 | Final date for Comment: 04 April 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide/Veterinary drug - Teflubenzuron

Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Code: 03.07) - 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

Maximum residue limits (MRLs) Human health Pesticides 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: 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

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

<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&amp;jornal=1&amp;pagina=12&amp;totalArquivos=56</p>

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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)

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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

Human health

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

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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

Human health

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