Amendment of the ANVISA Collegiate Board Resolution - RDC No. 350 of 19 March 2020.

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Distribution date: 13 October 2020 | Final date for Comment: 26 May 2025

The Resolution – RDC number 350, 19 March 2020 – previously notified through G/TBT/N/BRA/989 – which establishes exceptional criteria and procedure for the manufacturing and sale of antiseptic preparations and sanitizers without previous market authorization from ANVISA and provides other measures due to the international public health emergency related to the SARS-CoV-2, was changed by the Resolution – RDC number 422, 16 September 2020.

Products Covered: HS Code(s): 33079090, 38089990, 3402 (antiseptic preparations, sanitizer)

Regulation Type: Addendum to Regular Notification

E09. COVID-19 TBT

Resolution - RE number 3838, 24 September 2020

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Distribution date: 13 October 2020 | Final date for Comment: 26 May 2025

The Draft Resolution number 855, 7 July 2020 - previously notified through G/SPS/N/BRA/1722 - was adopted as Resolution - RE number 3838, 24 September 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=28/09/2020&jornal=515&pagina=578

Products Covered:

Regulation Type: Addendum to Regular Notification

Food safety Human health Pesticides Maximum residue limits (MRLs) Adoption/publication/entry into force of reg.

Resolution - RE number 3838, 24 September 2020

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Distribution date: 13 October 2020 | Final date for Comment: 26 May 2025

The Draft Resolution number 855, 7 July 2020 - previously notified through G/SPS/N/BRA/1722 - was adopted as Resolution - RE number 3838, 24 September 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=28/09/2020&jornal=515&pagina=578

Products Covered:

Regulation Type: Addendum to Regular Notification

Food safety Human health Pesticides Maximum residue limits (MRLs) Adoption/publication/entry into force of reg.

Resolution – RDC number 428, 7 October 2020

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Distribution date: 15 October 2020 | Final date for Comment: 26 May 2025

This Resolution changes the Resolution – RDC number 177, 21 September 2017, which provides for the ban on the active ingredient Paraquat in pesticides in the country and for transitional risk mitigation measures; and regulates the application of the stocks of the active ingredient Paraquat based  products under possession of the Brazilian farmers in the crops management of the agricultural harvest of 2020/2021.This Resolution will be also notified to the TBT committee.

Products Covered: HS Code(s): 38089910 ICS Code(s): 13

Regulation Type: Regular notification

Maximum residue limits (MRLs) Food safety Human health Pesticides

Resolution – RDC number 428, 7 October 2020

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Distribution date: 15 October 2020 | Final date for Comment: 26 May 2025

This Resolution changes the Resolution – RDC number 177, 21 September 2017, which provides for the ban on the active ingredient Paraquat in pesticides in the country and for transitional risk mitigation measures; and regulates the application of the stocks of the active ingredient Paraquat based  products under possession of the Brazilian farmers in the crops management of the agricultural harvest of 2020/2021.This Resolution will be also notified to the TBT committee.

Products Covered: HS Code(s): 38089910 ICS Code(s): 13

Regulation Type: Regular notification

Maximum residue limits (MRLs) Food safety Human health Pesticides

Draft resolution number 927, 9 October 2020, regarding the active ingredient I29 - ISOFETAMIDA (Isofetamid) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 16 October 2020 | Final date for Comment: 12 December 2020

This Draft Resolution includes the active ingredient I29 - ISOFETAMIDA (Isofetamid) in the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution number 927, 9 October 2020, regarding the active ingredient I29 - ISOFETAMIDA (Isofetamid) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 16 October 2020 | Final date for Comment: 12 December 2020

This Draft Resolution includes the active ingredient I29 - ISOFETAMIDA (Isofetamid) in the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution number 928, 9 October 2020, regarding the active ingredient I13 - IMIDACLOPRIDO (imidacloprid) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 16 October 2020 | Final date for Comment: 12 December 2020

This Draft resolution incorporates the following changes for the active ingredient I13 - IMIDACLOPRIDO (imidacloprid) 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 rye, millet, and triticale cultures with MRL of 0,5 mg/kg and safety security period of 30 days;-changes the MRL of the oat and barley cultures from 0,05 to 0,5 mg/kg;-changes the MRL of the sorghum culture from 0,1 to 0,5 mg/kg;-includes the phrase: "Acute Reference Dose (ARfD): 0.4 mg/kg b.w. (source: JMPR, 2001).

Products Covered: HS Code(s): 1002, 1003, 1004, 1007, 100820; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution number 928, 9 October 2020, regarding the active ingredient I13 - IMIDACLOPRIDO (imidacloprid) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 16 October 2020 | Final date for Comment: 12 December 2020

This Draft resolution incorporates the following changes for the active ingredient I13 - IMIDACLOPRIDO (imidacloprid) 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 rye, millet, and triticale cultures with MRL of 0,5 mg/kg and safety security period of 30 days;-changes the MRL of the oat and barley cultures from 0,05 to 0,5 mg/kg;-changes the MRL of the sorghum culture from 0,1 to 0,5 mg/kg;-includes the phrase: "Acute Reference Dose (ARfD): 0.4 mg/kg b.w. (source: JMPR, 2001).

Products Covered: HS Code(s): 1002, 1003, 1004, 1007, 100820; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 19 October 2020 | Final date for Comment: 18 December 2020

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Pyrifluquinazon

Products Covered: -Edible vegetables and certain roots and tubers (HS: 07.01, 07.02, 07.03, 07.04, 07.05, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) -Edible fruit and peel of citrus fruit (HS: 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -Tea and spices (HS: 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS: 10.05)-Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS: 12.01, 12.07 and 12.12)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Food safety Human health Pesticides

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