Regulatory Updates
Public Notice under the Commodity Inspection Act (5 pages, in English; 3 pages, in Chinese) (5 pages, in English; 3 pages, in Chinese).
Distribution date: 09 January 2017 | Final date for Comment: 10 March 2017
<p style="margin:6pt 0cm;"><span lang="EN-GB" style="letter-spacing:-0.1pt;">Drinking water supplier</span><span lang="EN-GB" style="letter-spacing:-0.1pt;">s (hereinafter referred as "the commodities") have been subject to mandatory inspection under the Commodity Inspection Act by the Bureau of Standards Metrology and Inspection (BSMI) since 1 May 1990. To enhance consumer protection and promote efficiency of energy use, the BSMI </span><span lang="EN-GB">proposes to adopt the latest version of inspection standards for</span><span lang="EN-GB"> <span style="letter-spacing:-0.1pt;">the commodities.</span></span></p><p style="margin:6pt 0cm;"><span lang="EN-GB" style="letter-spacing:-0.1pt;">In addition to the safety and energy efficiency requirements for the commodities, the BSMI </span><span lang="EN-GB" style="color:black;">proposes to require marking of presence conditions of hazardous substances to inform users the </span><span lang="EN-GB" style="color:black;">conditions</span><span lang="EN-GB" style="color:black;"> of 6 chemical substances in such products. </span><span lang="EN-GB">Such markings shall be made in accordance with Section 5 "Marking of Presence" of CNS 15663 on the body, packages, stickers or the instruction books of the commodities. For those who utilize website as a means to announce "the presence conditions of the restricted substances of the commodities," the website address shall be clearly stated on the body, packages, stickers or the instruction books of the commodities.</span><strong></strong></p><span lang="EN-CA" style="font-family:'Verdana','sans-serif';font-size:9pt;">The conformity assessment procedures for products subject to this notified measure remain the same, i.e. Registration of Products Certification (RPC) or Type-approved Batch Inspection (TABI).</span>
Products Covered: Drinking water supplier (CCCN 8418.69.90.00.9A, 8516.10.00.00.9D). Other refrigerating or freezing equipment (HS: 841869). Electric instantaneous or storage water heaters and immersion heaters (HS: 851610)
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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide/Veterinary drug: Etoxazole.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.06, 02.07 and 02.09) - Dairy produce and birds' eggs (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: 07.07, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 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) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.07 and 12.10) - 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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Isouron.
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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Profenofos.
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 and birds' eggs (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)
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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Hexythiazox.
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 and birds' eggs (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, 07.07, 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, 12.10 and 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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Tolfenamic acid.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03 and 02.06) - Dairy produce (HS Code: 04.01) - Products of animal origin (HS Code: 05.04) - 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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Prohydrojasmon.
Products Covered: - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.05, 08.06, 08.08 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)
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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Prometryn.
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 (HS Code: 04.01) - 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: 08.07, 08.10 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 Codes: 12.01, 12.02, 12.06, 12.07 and 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: 20 December 2016 | Final date for Comment: 18 February 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Cymoxanil.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.07, 07.08, 07.09, 07.10 and 07.13) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.06, 08.07, 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) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.06 and 12.10)
Regulation Type: Regular notification
<pre><p>TITLE: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule; correction</p><p>SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule entitled "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs" that appeared in the Federal Register of 31 August 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error.</p><p>Effective 13 December 2016.</p></pre>
Distribution date: 19 December 2016
Products Covered: Human and animal drugs (HS Chapter 3004; ICS: 11.120, 11.220)
Regulation Type: Corrigendum to Regular Notification
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