Draft resolution number 676, 29 July 2019, regarding the active ingredient I10 – IMAZETAPIR 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: 15 August 2019 | Final date for Comment: 30 September 2019

This Draft resolution incorporates the following changes for the active ingredient I10 – IMAZETAPIR from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality and of pre/post-emergency use(application): - includes the ground-nut culture with MRL 0.1 mg/kg and safety security period not determined because of the modality of application.

Products Covered: HS Code(s): 1202; ICS Code(s): 13, 65

Regulation Type: Regular notification

Pesticides Maximum residue limits (MRLs) Food safety Human health

Draft resolution number 670, 29 July 2019, regarding the active ingredient o F47 – FLUAZINAM 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: 15 August 2019 | Final date for Comment: 30 September 2019

This Draft resolution incorporates the following changes for the active ingredient F47 – FLUAZINAM of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use(application):- includes the lettuce, watercress, witloof chicory, chicory, spinach, rucola, mustard, chard and stevia rebaudiana cultures with MRL of 2.0 mg/kg and safety security period of 14 days;- includes the blackberry and pitanga cultures with MRL of 2.0 mg/kg and safety security period of 3 days;- includes the item "k" acceptable daily intake (ADI) of 0.01mg/kg.

Products Covered: HS Codes: 07051, 070521, 07052, 070970, 210330, 081020, 070990, 12099110, 12119029, rucola, pitanga; ICS Codes: 13, 65

Regulation Type: Regular notification

Food safety Maximum residue limits (MRLs) Human health Pesticides

Draft resolution number 673, 29 July 2019, regarding the active ingredient T32 – TEBUCONAZOL 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: 15 August 2019 | Final date for Comment: 30 September 2019

This Draft resolution incorporates the following changes for the active ingredient T32 – TEBUCONAZOL from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality and of foliar use(application): - changes the safety security period of the citrus culture from 20 to 5 days.

Products Covered: HS Code(s): 0805; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution number 677, 29 July 2019, regarding the active ingredient F46 - FLUMIOXAZINA 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: 15 August 2019 | Final date for Comment: 30 September 2019

This Draft resolution incorporates the following changes for the active ingredient F46 - FLUMIOXAZINA from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality and of pre/post-emergency use (application): - includes the ground-nut culture with MRL 0.1 mg/kg and safety security period not determined because of the modality of application.

Products Covered: HS Code(s): 200811; ICS Code(s): 13, 65

Regulation Type: Regular notification

Pesticides Maximum residue limits (MRLs) Food safety Human health

Draft resolution number 656, 17 June 2019, regarding the active ingredient P54 - PROEXADIONA CÁLCICA 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: 15 August 2019 | Final date for Comment: 18 August 2019

This Draft resolution incorporates the following changes for the active ingredient P54 - PROEXADIONA CÁLCICA 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 MRL of 0.01mg/kg and the safety security period of 15 days for the grape culture.

Products Covered: HS Code(s): 0806; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-SA-7/21044 of 13 August 2019

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Distribution date: 15 August 2019 | Final date for Comment: 06 May 2025

This letter introduces a temporary restriction on import of live swine, meat of swine and products containing pork, embryos of swine and boar semen from Republic of Serbia.

Products Covered: Live swine, meat of swine, meat and edible meat offal, swine embryos and boar' semen with the exception of prepared heat-treated goods of pork, prepared goods containing pork or raw materials of animal origin (from pork) for the feeds production (for non-productive animals and fur) animals with the use of technologies providing destruction of ASF in accordance with the provision of Chapter 15.1 of the OIE Terrestrial Animal Health Code.

Regulation Type: Emergency notifications (SPS)

Animal diseases Food safety African swine fever (ASF) Animal health Human health Zoonoses

Ordinance 154, 08 August 2019 (Portaria MAPA 154, de 08 de Agosto de 2019) published by the Brazilian Official Gazette No. 154 on 12 August 2019

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Distribution date: 15 August 2019 | Final date for Comment: 26 August 2019

The notified regulation opens a 45-day period for public consultation on the draft of a technical regulation that aims to define the formulation requirements, production, quality control and labelling of products for hygiene and beauty care for animals and make their registration mandatory with automatic granting by the Ministry of Agriculture, Livestock and Supply.

Products Covered: HS 3002.90.90 – Other animal products

Regulation Type: Regular notification

Labelling

Ordinance 153, 08 August 2019 (Portaria MAPA 153, de 08 de Agosto de 2019) published by the Brazilian Official Gazette No. 154 on 12 August 2019

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Distribution date: 15 August 2019 | Final date for Comment: 26 September 2019

The notified regulation opens a 45-day period for public consultation on the draft of a technical regulation for production, control and use of autogenous vaccines.

Products Covered: HS 3002.30 - Veterinary vaccines

Regulation Type: Regular notification

Draft Normative Instruction number 689, August 12th, 2019. Published on D.O.U, August 14th, 2019. Language(s): Portuguese. Number of pages: 4. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49395

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Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019

This draft resolution establishes guidelines for authorization of suppliers related to the Technical Regulation for Good Practice of Distribution and Fractioning of Active Pharmaceutical Ingredients (API).

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Regular notification

Draft Resolution number 683, August 12th, 2019. Published on D.O.U, August 14th, 2019. Language(s): Portuguese. Number of pages: 16 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49362

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Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019

This draft resolution proposes the changing of the Resolution – RDC number 200, December 26th, 2017, and of the RDC number 73, April 7th, 2016, for the submission of the Dossier for Active Pharmaceutical Ingredient (API) in the market authorization and post-market authorization of medicines, respectively.

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Regular notification

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