Regulatory Updates
Partial amendment to the Minimum Requirements for Radiopharmaceuticals
Distribution date: 03 July 2025 | Final date for Comment: 02 August 2025
The Minimum Requirements for Radiopharmaceuticals are to be partially amended to add the standards for radiopharmaceuticals to be newly approved.
Products Covered: Pharmaceutical products (HS: 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological ProductsPartial amendment to the Public Notice on National Release Testing
Distribution date: 03 July 2025 | Final date for Comment: 02 August 2025
The Minimum Requirements for Biological Products will be amended as follows:Regarding the article of “Inactivation test” in the section of “Tests on final product” of the monograph for “High dose Influenza HA Vaccine”, the rule of inoculating with the allantoic fluid into allantoic cavities of eggs in case there are positive hemagglutination test results will be partially amended. And regarding the standard for “Pneumococcal Polyvalent Vaccine”, the section of “Serological identification test” will be deleted. In addition, the standard for “21-valent Pneumococcal Conjugate Vaccine” that is to be newly approved will be added. The Public Notice on National Release Testing will be amended as follows: The criterion, fee, quantity and Institution for National Release Testing for “21-valent Pneumococcal Conjugate Vaccine” that is to be newly approved will be added.
Products Covered: Pharmaceutical products (HS: 30)
Regulation Type: 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: 03 July 2025
The proposed maximum residue limits (MRLs) for Quinofumelin notified in G/SPS/N/JPN/1281 (dated 9 September 2024) were adopted and published on 10 February 2025. 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)Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.13)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10,08.11 and 08.14)Tea and spices (HS codes: 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS code: 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.07 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: 03 July 2025
The proposed maximum residue limits (MRLs) for Fenitrothion notified in G/SPS/N/JPN/1282 (dated 9 September 2024) were adopted and published on 10 February 2025. 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)Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.02, 08.04, 08.05, 08.06, 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 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, 12.07 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: 03 July 2025
The proposed maximum residue limits (MRLs) for Tylosin notified in G/SPS/N/JPN/1292 (dated 9 September 2024) were adopted and published on 10 February 2025. 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, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)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: 03 July 2025
The proposed maximum residue limits (MRLs) for Sulfachlorpyridazine notified in G/SPS/N/JPN/1283 (dated 9 September 2024) were adopted and published on 10 February 2025. The specified MRLs are available as below:
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.06 and 02.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.01 and 15.02)
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: 03 July 2025
The proposed maximum residue limits (MRLs) for Cyflumetofen notified in G/SPS/N/JPN/1278 (dated 9 September 2024) were adopted and published on 10 February 2025. 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, 02.08 and 02.09)Dairy produce and natural honey (HS codes: 04.01 and 04.09)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.04, 07.07, 07.08, 07.09, 07.10 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)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)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 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: 03 July 2025
The proposed maximum residue limits (MRLs) for Fluopyram notified in G/SPS/N/JPN/1301 (dated 4 October 2024) were adopted and published on 27 February 2025. 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, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)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, mate and spices (HS codes: 09.01, 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)
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: 03 July 2025
The proposed maximum residue limits (MRLs) for 1-Naphthaleneacetic acid notified in G/SPS/N/JPN/1304 (dated 4 October 2024) were adopted and published on 27 February 2025. The specified MRLs are available as below:
Products Covered: Natural honey (HS code: 04.09)Edible vegetables and certain roots and tubers (HS codes: 07.09 and 07.10)Edible fruit and peel of citrus fruit (HS codes: 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Tea and spices (HS codes: 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 code: 12.07)
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: 03 July 2025
The proposed maximum residue limits (MRLs) for Sulfamethoxazole notified in G/SPS/N/JPN/1288 (dated 9 September 2024) were adopted and published on 10 February 2025. The specified MRLs are available as below:
Products Covered: Meat and edible meat offal (HS codes: 02.03, 02.06, 02.07 and 02.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.01)
Regulation Type: Addendum to Regular Notification
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