Distribution date: 08 March 2021 | Final date for Comment: 16 May 2025

This Notice of Amendment notifies of the amendment the Prescription Drug List (PDL) qualifier for Vitamin D to allow non-prescription status to products containing up to 62.5 µg or 2,500 International Units (IU)/day for oral use. Only the Human part of the PDL has been revised.  

Products Covered: Prescription status of medicinal ingredients for human use

Regulation Type: Regular notification

Distribution date: 09 March 2021 | Final date for Comment: 16 May 2025

The annex I of the Normative Instruction number 51, 19 November 2019 - previously notified through G/SPS/N/BRA/1527/Add.2 - which establishes the MRL for veterinary drugs in food 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-305691624.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient I05 - IPRODIONA (iprodione) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the oats culture with MRL of 2.0 mg/kg and safety security period of 5 days;- includes the barley culture with MRL of 2.0 mg/kg and safety security period of 5 days;- includes the phrase at item "m": "Acute Reference Dose (ARfD): Not applicable (source: JMPR*, 2001)";- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase at item "n": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient iprodione".

Products Covered: HS Code(s): 1003, 1004; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient T54 - TRIFLOXISTROBINA (trifloxystrobin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the coconut culture with MRL of 0.01 mg/kg and safety security period of 1 day;- includes the pumpkin culture with MRL of 0.2 mg/kg and safety security period of 1 day;- includes the phrase: "for the purpose of residue definition for conformity to MRL, it will be considered the active ingredient trifloxystrobin, and for dietary risk assessment, it will be considered the sum of the active ingredient trifloxystrobin with its metabolite acid (E,E)-methoxyimino-{2-[1-(3- trifluorometilophenyl)-ethylideneamino-oximethyl]-phenyl}-acetic (CGA 321113), expressed as trifloxystrobin";- includes the phrase: "Acute Reference Dose (ARfD): Not applicable (source: JMPR*, 2004)";- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues".

Products Covered: HS Code(s): 08011, 07099300; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient F47 - FLUAZINAM (fluazinam) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of the peanut, chickpea, and lentil cultures from 0.01 to 0.1 mg/kg;- changes the MRL of the pea and caupi bean cultures from 0.05 to 0.1 mg/kg;- changes the MRL of the soya culture from 0.01 to 0.02 mg/kg;- includes the phrase: "Acute Reference Dose (ARfD): 0.07 mg/kg b.w. (Source: EFSA, 2008)."

Products Covered: HS Code(s): 1201, 1202, 071320, 071340, 070810, 07133500; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient C59 - BETA-CIPERMETRINA (beta-cypermethrin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the millet culture with MRL of 0.05 mg/kg and safety security period of 14 days;- includes the sorghum culture with MRL of 1.0 mg/kg and safety security period of 14 days.

Products Covered: HS Code(s): 1007, 10082; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient C10 - CIPERMETRINA (cypermethrin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the sweet potato, yacon, beetroot, greater yam, carrot, pea, bean, ginger, chickpea, yams, lentil, arracacha, turnip, and radish cultures with safety security period of 14 days;- changes the safety security period of the peanut from 22 to 14 days;- includes the bean, chickpea, and lentil cultures with MRL of 0.05 mg/kg in the general table for cypermethrins;- changes the MRL of the yacon, greater yam, pea, turnip and radish from 0.02 to 0.05 mg/kg in the general table for cypermethrins;- includes the phrase at item "o": "Acute Reference Dose (ARfD): 0.04 mg/kg b.w. (source: JMPR*, 2006)";- includes the phrase: "*Joint FAO/WHO Meeting on Pesticides".

Products Covered: HS Code(s): 1202, 071420, 0706, 070820, 070810, 09101, 071430, 071320, 17029040000, 07143000, 0714900011; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 16 March 2021 | Final date for Comment: 16 May 2025

The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would like to notify that the "Regulation for the Use Restrictions and Labeling Requirements of Astaxanthin Produced by Genetically Modified Escherichia coli Strain Ast12 as a Food Ingredient," as per G/TBT/N/TPKM/418 on 22 June 2020, was promulgated on 11 March 2021 and came into effect on the same day.

Products Covered: Food ingredient to be used in food

Regulation Type: Addendum to Regular Notification

Distribution date: 17 March 2021 | Final date for Comment: 16 May 2025

The Draft Resolution number 927, 9 October 2020 - previously notified through G/SPS/N/BRA/1789 - was adopted as Resolution - RE number 1053, 11 March 2021.The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=15/03/2021&jornal=515&pagina=136.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 18 March 2021 | Final date for Comment: 17 May 2021

This regulation specifies the following: Terms and Definitions, Scope, Objectives, Supplier Obligations, Labelling, Conformity Assessment Procedures, Responsibilities of Regulatory Authorities, Responsibilities of Market Surveillance Authorities, Violations and Penalties, General Provisions, Transitional Provisions, Appendix (lists, types, safety and health requirements)

Products Covered: 3703, 3704, 4801, 4802, 4803, 4804, 4805, 4806, 4807, 4808, 4809, 4810, 4811, 4812, 4817, 4818, 4819, 4820, 4821, 4822, 4823

Regulation Type: Regular notification