Regulatory Updates
Partial amendment to the Minimum Requirements for Biological Products.Partial amendment to The Public Notice on National Release Testing.
Distribution date: 09 June 2023 | Final date for Comment: 09 July 2023
The Minimum Requirements for Biological Products will be amended as follows；The standard name of “nucleoside modified coronavirus RNA Vaccine (SARS-CoV-2)” will be amended to “coronavirus (SARS-CoV-2) RNA Vaccine”. Accordingly, the test for pH, storage and expiry date will be deleted and partially amended for the above-mentioned vaccine. The Public Notice on National Release Testing will be amended as follows； The standard name of “nucleoside modified coronavirus RNA Vaccine (SARS-CoV-2)” will be amended to “coronavirus (SARS-CoV-2) RNA Vaccine”. In addition, the criterion of “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Haemophilus TYPE b Combined Vaccine” will be partially amended. Accordingly, the fee, criterion, and quantity for National Release Testing of the above-mentioned vaccine will be partially amended.
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: 09 June 2023
The proposed maximum residue limits (MRLs) for Zoxamide notified in G/SPS/N/JPN/1158 (dated 2 December 2022) were adopted and published on 26 April 2023.The specified MRLs are available as below:
Products Covered: Natural honey (HS code: 04.09) Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.06, 08.07 and 08.11)
Regulation Type: Addendum to Regular Notification
Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products
Distribution date: 08 June 2023 | Final date for Comment: 07 August 2023
The measures proposed by the draft Commission Regulation are part of the on-going and regular adaptations of the Annexes to Regulation (EC) No 1223/2009 (Cosmetics Regulation - CPR). Based on the latest scientific opinions by the Scientific Committee on Consumer Safety (SCCS) the proposed measures aim at: - prohibiting the use of 4-MBC (i.e., delisting this UV-filter from Annex VI and introducing it in Annex II to the CPR);- establishing restrictions in Annex III for the substance 'Genistein', used as skin conditioning/protecting and antioxidant in cosmetic products;- establishing restrictions in Annex III for the substance 'Daidzein', used as skin conditioning/protecting and antioxidant in cosmetic products;- establishing restrictions in Annex III for the substance 'Kojic Acid', used as skin lightening/whitening or depigmenting agent in cosmetic products;- further restricting the use of the preservative 'Triclosan' in cosmetic products by amending the existing restrictions in Annex V;- further restricting the use of the preservative 'Triclocarban' in cosmetic products by amending the existing restrictions in Annex V; - establishing restrictions in Annex III for the Vitamin A compounds ‘Retinol’, ‘Retinyl Acetate’ and ‘Retinyl Palmitate’ used as skin conditioning agent in cosmetic products;- establishing restrictions in Annex III for the substance ‘Alpha-Arbutin’ used as skin bleaching and skin conditioning agents in cosmetic products;- establishing restrictions in Annex III for the substance ‘Arbutin’ used as skin bleaching and skin conditioning agents in cosmetic products.
Products Covered: Cosmetics
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: 08 June 2023
The proposed maximum residue limits (MRLs) for Pyraziflumid notified in G/SPS/N/JPN/1155 (dated 2 December 2022) were adopted and published on 26 April 2023.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: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13) Edible fruit and nuts, peel of citrus fruit (HS codes: 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) Mate and spices (HS codes: 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: 12.01 and 12.07) 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: 08 June 2023
The proposed maximum residue limits (MRLs) for Isopyrazam notified in G/SPS/N/JPN/1154 (dated 2 December 2022) were adopted and published on 26 April 2023.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: 07.02, 07.04, 07.05, 07.06, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.04, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.07 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.02 and 12.05) 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: 08 June 2023
The proposed maximum residue limits (MRLs) for Flutriafol notified in G/SPS/N/JPN/1153 (dated 2 December 2022) were adopted and published on 26 April 2023.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: 07.02, 07.04, 07.05, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) Coffee (HS code: 09.01) Cereals (HS codes: 10.01, 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, 12.05, 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: 08 June 2023
The proposed maximum residue limits (MRLs) for Trinexapac-ethyl notified in G/SPS/N/JPN/1157 (dated 2 December 2022) were adopted and published on 26 April 2023.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) Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.06, 10.07 and 10.08) Products of the milling industry (HS code: 11.03) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.05 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: 08 June 2023
The proposed maximum residue limits (MRLs) for Pyridalyl notified in G/SPS/N/JPN/1156 (dated 2 December 2022) were adopted and published on 26 April 2023.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 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 (HS codes: 08.07, 08.10 and 08.11) Mate and spices (HS code: 09.03 and 09.10) Cereals (HS codes: 10.05 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.12)
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: 08 June 2023
The proposed maximum residue limits (MRLs) for Fludioxonil notified in G/SPS/N/JPN/1152 (dated 2 December 2022) were adopted and published on 26 April 2023.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: 07.01, 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) 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) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.04, 12.05, 12.06, 12.07 and 12.12) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Addendum to Regular Notification
Draft Law of the Republic of Lithuania on Control of Certain Doping Substances on Amendment of Article 2, XIVP-1496(2)
Distribution date: 07 June 2023
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Addendum to Regular Notification
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