Regulatory Updates
Draft resolution number 853, 23 June 2020, regarding the active ingredient F69 - FLUPIRADIFURONE (flupyradifurone) 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
Distribution date: 16 July 2020 | Final date for Comment: 29 August 2020
This Draft resolution incorporates the following changes for the active ingredient F69 - FLUPIRADIFURONE (flupyradifurone) 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 safety security period of the potato culture from 7 to 3 days;-changes the MRL of the coffee culture from 0,5 to 1,5 mg/kg;-includes the soya culture with MRL of 0,4 mg/kg and safety security period 14 days;-changes the phrase at item "i" from "class III (medium toxic)" to "specific for each product, in compliance with article 38 of the Resolution - RDC number 294, 29 July 2019";-changes the phrase at item "j": "for the purpose of residue definition for conformity to MRL and for the dietary risk assessment it will be considered the ingredient flupyradifurone and its metabolite acid difluoroacetic (DFA), expressed as flupyradifurone";-includes the phrase: "acute reference dose (ARfD)=0,2 mg/kg p.c. (source: JMPR, 2015)";-includes the phrase: "inclusion of the cultures requested by the Joint Normative Instruction number 01, 16 June 2014";-includes the phrase: "Joint FAO/WHO Meeting on Pesticide Residues".
Products Covered: HS Code(s): 071010, 09, 1201; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 853, 23 June 2020, regarding the active ingredient F69 - FLUPIRADIFURONE (flupyradifurone) 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
Distribution date: 16 July 2020 | Final date for Comment: 29 August 2020
This Draft resolution incorporates the following changes for the active ingredient F69 - FLUPIRADIFURONE (flupyradifurone) 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 safety security period of the potato culture from 7 to 3 days;-changes the MRL of the coffee culture from 0,5 to 1,5 mg/kg;-includes the soya culture with MRL of 0,4 mg/kg and safety security period 14 days;-changes the phrase at item "i" from "class III (medium toxic)" to "specific for each product, in compliance with article 38 of the Resolution - RDC number 294, 29 July 2019";-changes the phrase at item "j": "for the purpose of residue definition for conformity to MRL and for the dietary risk assessment it will be considered the ingredient flupyradifurone and its metabolite acid difluoroacetic (DFA), expressed as flupyradifurone";-includes the phrase: "acute reference dose (ARfD)=0,2 mg/kg p.c. (source: JMPR, 2015)";-includes the phrase: "inclusion of the cultures requested by the Joint Normative Instruction number 01, 16 June 2014";-includes the phrase: "Joint FAO/WHO Meeting on Pesticide Residues".
Products Covered: HS Code(s): 071010, 09, 1201; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 852, 23 June 2020, regarding the active ingredient D55 - DINOTEFURAN (dinotefuran) 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
Distribution date: 16 July 2020 | Final date for Comment: 29 August 2020
This Draft resolution incorporates the following changes for the active ingredient D55 - DINOTEFURAN (dinotefuran) 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 ground-nut, pea, beans, chickpea, and lentil cultures with MRL of 0,09 mg/kg and safety security period of 14 days;-includes the sorghum culture with MRL of 0,01 mg/kg and safety security period of 21 days;-changes the safety security period of the cane sugar culture from 210 to 150 days.
Products Covered: HS Code(s): 200811, 070810, 070820, 071320, 071340, 1007, 170111; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 852, 23 June 2020, regarding the active ingredient D55 - DINOTEFURAN (dinotefuran) 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
Distribution date: 16 July 2020 | Final date for Comment: 29 August 2020
This Draft resolution incorporates the following changes for the active ingredient D55 - DINOTEFURAN (dinotefuran) 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 ground-nut, pea, beans, chickpea, and lentil cultures with MRL of 0,09 mg/kg and safety security period of 14 days;-includes the sorghum culture with MRL of 0,01 mg/kg and safety security period of 21 days;-changes the safety security period of the cane sugar culture from 210 to 150 days.
Products Covered: HS Code(s): 200811, 070810, 070820, 071320, 071340, 1007, 170111; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 851, 23 June 2020, regarding the active ingredient S20 - Saccharomyces cerevisiae of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003
Distribution date: 16 July 2020 | Final date for Comment: 29 August 2020
This Draft resolution includes the active ingredient S20 - Saccharomyces cerevisiae 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
Draft resolution number 851, 23 June 2020, regarding the active ingredient S20 - Saccharomyces cerevisiae of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003
Distribution date: 16 July 2020 | Final date for Comment: 29 August 2020
This Draft resolution includes the active ingredient S20 - Saccharomyces cerevisiae 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
The draft regulation on the "Review and Approval of Advanced Biological Products"
Distribution date: 13 July 2020 | Final date for Comment: 02 August 2020
As the Act on the Safety and Support of Advanced Biological Products was established, the Regulations on the Review and Approval of Advanced Biological Products was enacted to stipulate document requirements and evaluation criteria for the approval of advanced biological products.
Products Covered: Advanced Biological Products (HS: 3004-90-9900)
Regulation Type: Regular notification
The draft regulation on the "Review and Approval of Advanced Biological Products"
Distribution date: 13 July 2020 | Final date for Comment: 02 August 2020
As the Act on the Safety and Support of Advanced Biological Products was established, the Regulations on the Review and Approval of Advanced Biological Products was enacted to stipulate document requirements and evaluation criteria for the approval of advanced biological products.
Products Covered: Advanced Biological Products (HS: 3004-90-9900)
Regulation Type: Regular notification
This addendum aims to inform that the National Institute of Metrology, Quality and Technology - INMETRO, issued Draft Ordinance no. 217, of 18 June 2020, which proposes to make adjustments in order to clarify the excerpts from the Technical Quality Regulation (RTQ) and the Quality Requirements Conformity Assessment (RAC) for School Articles, established by Ordinance Inmetro No. 481, of 07 December 2010. The Draft Normative Instruction number 217, 18 June 2020 – previously notified through G/TBT/N/BRA/375/Add.7 – amends Inmetro Ordinance No. 481 of 07 December 2010, which approves the Conformity Assessment Requirements for School Articles. Inmetro Ordinance No. 217, of 18 June 2020 revokes the Inmetro Ordinance No. 598 of 26 December 2018, published in the Brazilian Official Gazette No. 248 of 27 December 2018, section 01, page 106. This regulation enters into force on the day of publication in Brazilian Official Gazette. The full text is available in Portuguese and can be downloaded at:
Distribution date: 13 July 2020
Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.
Regulation Type: Addendum to Regular Notification
This addendum aims to inform that the National Institute of Metrology, Quality and Technology - INMETRO, issued Draft Ordinance no. 217, of 18 June 2020, which proposes to make adjustments in order to clarify the excerpts from the Technical Quality Regulation (RTQ) and the Quality Requirements Conformity Assessment (RAC) for School Articles, established by Ordinance Inmetro No. 481, of 07 December 2010. The Draft Normative Instruction number 217, 18 June 2020 – previously notified through G/TBT/N/BRA/375/Add.7 – amends Inmetro Ordinance No. 481 of 07 December 2010, which approves the Conformity Assessment Requirements for School Articles. Inmetro Ordinance No. 217, of 18 June 2020 revokes the Inmetro Ordinance No. 598 of 26 December 2018, published in the Brazilian Official Gazette No. 248 of 27 December 2018, section 01, page 106. This regulation enters into force on the day of publication in Brazilian Official Gazette. The full text is available in Portuguese and can be downloaded at:
Distribution date: 13 July 2020
Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.
Regulation Type: Addendum to Regular Notification
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