Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021 | Final date for Comment: 15 May 2025
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Feed additive: Dibutylhydroxytoluene.
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, 03.04 and 03.06)-Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) -Animal originated products (HS Code: 05.04)-Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Fenpropathrin
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) -Animal originated products (HS Code: 05.04) -Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.04, 07.07, 07.09, 07.10 and 07.13) -Edible fruit, nuts and peel of citrus fruit (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 and spices (HS Codes: 09.01, 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07 and 12.10)-Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021 | Final date for Comment: 15 May 2025
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Kasugamycin
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 07.13) -Edible fruit, nuts and peel of citrus fruit (HS Codes: 08.02, 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -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: 10.06)-Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.07 and 12.12)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (revision of Agricultural Chemical Residue Standards)
Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Prochloraz
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) -Animal originated products (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 fruit, nuts and peel of citrus fruit (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) -Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (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, 15.06 and 15.12)
Regulation Type: Regular notification
Proposed new standard for medicine serialisation and data matrix codes - Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021
Distribution date: 01 April 2021 | Final date for Comment: 15 May 2025
In March 2021, a new standard, Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 was registered on the Federal Register of Legislation. The standard commences on 1 January 2023. TGO 106 does not mandate medicine serialisation or the application of data matrix codes to medicines, but sets out the technical requirements if the medicine sponsor implements either of these. Medicines released for supply from 1 January 2023 must comply with the requirements of TGO 106 if they: are serialised include a data matrix code which encodes the Global Trade Item Number (GTIN). TGO 106 defines the requirements for the presentation and content of data matrix codes including human readability requirements and relationship with other machine readable codes. The requirements include: Where a medicine is serialised this must be represented by a serial number encoded into a data matrix code that complies with the GS1 General Specifications for a DataMatrix. If a data matrix code containing a GTIN is applied to a unit of a medicine, this must be formatted as a GS1 DataMatrix that complies with the GS1 General Specifications. TGO 106 does not set out any requirements regarding reporting, storage and verification of serialisation data.
Products Covered: Medicines
Regulation Type: Addendum to Regular Notification
1) Partial amendment to the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and 2) Partial amendment to the Public Notice on Designated Biological Products under Article 197, Paragraph 2 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices
Distribution date: 06 April 2021 | Final date for Comment: 05 June 2021
The Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and the Public Notice on Designated Biological Products under Article 197, Paragraph 2 of the Regulation for Enforcement will be partially amended to reflect the World Health Organization (WHO) standard on Summary Lot Protocol (SLP).
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
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; Corrections AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS) ACTION: Final rule; correcting amendments SUMMARY: On 31 August 2016, the Food and Drug Administration (FDA or Agency) published an amended final rule that listed inaccurate cross- references to FDA's drug establishment registration and drug listing regulations. This document corrects the inaccurate cross-references used in the final regulations. This rule is effective 1 April 2021. This final rule; correcting amendments and previous actions notified under the symbol G/TBT/N/USA/214 are identified by Docket Number FDA-2005-N-0464. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2005-N-0464/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.
Distribution date: 06 April 2021 | Final date for Comment: 15 May 2025
Products Covered: Human and animal drugs (HS Chapter 3004; ICS: 11.120, 11.220)
Regulation Type: Corrigendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021 | Final date for Comment: 15 May 2025
The proposed maximum residue limits (MRLs) for Cyflufenamid notified in G/SPS/N/JPN/786 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021 | Final date for Comment: 15 May 2025
The proposed maximum residue limits (MRLs) for Azoxystrobin notified in G/SPS/N/JPN/784 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 07 April 2021 | Final date for Comment: 15 May 2025
The proposed maximum residue limits (MRLs) for Pyrifluquinazon notified in G/SPS/N/JPN/787 (dated 19 October 2020) were adopted and published on 3 February 2021.The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
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