Regulatory Updates
International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names
Distribution date: 10 November 2022 | Final date for Comment: 09 January 2023
The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of International harmonisation of ingredient names (IHIN). The TGA is conducting a public consultation between November and December 2022 to seek feedback on:whether health professionals, consumers and health systems are ready for dual labelling to end for all ingredient names currently required to be dual labelleda proposal to transition medicine labels and PI/CMI documents to sole medicine ingredient names in a specific time frame (for names suitable for transition).
Products Covered: Medicines
Regulation Type: Regular notification
Normative Instruction number 162, 01 July 2022
Distribution date: 08 November 2022
The Normative Instruction number 162, 01 July 2022 - previously notified through G/TBT/N/BRA/1417 - which establishes the acceptable daily intake (ADI), the acute reference dose (DRfA) and maximum residue limits (MRL) for active pharmaceuticals ingredients (API) of veterinary drugs in foods of animal origin, was rectified. The rectified text is available only in Portuguese and can be downloaded at:https://www.in.gov.br/en/web/dou/-/retificacao-437616621 __________
Products Covered: Pharmaceutical goods specified in Note 4 to this Chapter. (HS code(s): 3006)
Regulation Type: Corrigendum to Regular Notification
Rectification of Art. 4 of Inmetro Ordinance No. 420, 4 October 2021, published in the Official Gazette on 14 October 2021, pages 42 to 51, section 1.
Distribution date: 07 November 2022
The rectification text is available only in Portuguese and can be downloaded at:https://www.in.gov.br/web/dou/-/retificacao-441278456
Products Covered: Prepared or preserved meat or offal of bovine animals (excl. sausages and similar products, finely homogenised preparations put up for retail sale as infant food or for dietetic purposes, in containers of a net weight of
Regulation Type: Corrigendum to Regular Notification
Resolution – RDC Nº 567, 29 September 2021
Distribution date: 04 November 2022
The Resolution – RDC Nº 567, 29 September 2021 - previously notified through G/TBT/N/BRA/910/Add.3, has its deadline extended by Resolution - RDC number 756, 26 October 2022 The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6332458/RDC_756_2022_.pdf/a7b2088c-79cc-4128-bb65-4395b9381834
Products Covered: HS CODE: 3006 (radiopharmaceuticals)
Regulation Type: Addendum to Regular Notification
Amendment to the Ordinance for Enforcement of the Food Sanitation Act and the Specifications and Standards for Foods, Food Additives, Etc. (final rule)
Distribution date: 04 November 2022
The authorization of Potassium hydrogen carbonate as a food additive and establishment of the specifications and the standards notified in G/SPS/N/JPN/958 (dated 5 April 2022) were adopted and published on 30 August 2022.
Products Covered: Food additive (Potassium hydrogen carbonate)
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: 04 November 2022
The proposed maximum residue limits (MRLs) for Metominostrobin notified in G/SPS/N/JPN/962 (dated 5 April 2022) were adopted and published on 30 August 2022.The specified MRLs are available as below:
Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)- Edible fruit and nuts (HS Codes: 08.04 and 08.11)- Cereals (HS Code: 10.06)
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: 04 November 2022
The proposed maximum residue limits (MRLs) for Bentazone notified in G/SPS/N/JPN/964 (dated 5 April 2022) were adopted and published on 30 August 2022.The specified MRLs are available as below:
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 and nuts, 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 fats and oils (HS Codes: 15.01, 15.02 and 15.06)- Cocoa (HS Code: 18.01)
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: 04 November 2022
The proposed maximum residue limits (MRLs) for Triflumizole notified in G/SPS/N/JPN/959 (dated 5 April 2022) were adopted and published on 30 August 2022.The specified MRLs are available as below:
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, 03.06, 03.07 and 03.08)- 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: 07.02, 07.03, 07.04, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14)- Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.04, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11)- Tea and spices (HS Codes: 09.02 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: 12.10 and 12.12)- Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)
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: 04 November 2022
The proposed maximum residue limits (MRLs) for Permethrin notified in G/SPS/N/JPN/957 (dated 5 April 2022) were adopted and published on 30 August 2022.The specified MRLs are available as below:
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 and nuts, peel of citrus fruit (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: 09.01, 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, 10.07 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 fats and oils (HS Codes: 15.01, 15.02 and 15.06)
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: 04 November 2022
The proposed maximum residue limits (MRLs) for 1-Naphthaleneacetic acid notified in G/SPS/N/JPN/961 (dated 5 April 2022) were adopted and published on 30 August 2022.The specified MRLs are available as below:
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.09 and 07.10)- Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)- Spices (HS Codes: 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 Code: 12.07)
Regulation Type: Addendum to Regular Notification
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