The Normative Instruction number 38, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.5 – which adopts Complementary guidelines to the manufacture of medicinal gases of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020 | Final date for Comment: 10 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 39, August 21st, 2019 – previously notified through G/TBT/N/BRA/870/Add.6 – which adopts Complementary guidelines to the manufacture of herbal medicinal products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of July 1st, 2018, was republished. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020 | Final date for Comment: 10 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 43, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.10 – which adopts Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020 | Final date for Comment: 10 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Revision of the administrative rule of the Official Standards for Fertilizers
Distribution date: 19 March 2020 | Final date for Comment: 18 April 2020
Considering technical advancement and needs for complex fertilizers, the MAFF will revise the administrative rule of the Official standards for fertilizer in order to achieve the progress and sustainability of agricultural productivity and to protect human health. The following agricultural chemicals will be permitted to add a fertilizer as the official standards (Annex 1). (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine potassium(R)-2-(4-chloro-o-tolyloxy)propionate and 2,6-dichlorobenzonitrile
Products Covered: Fertilizer (HS: 3102, 3103, 3104, 3105)
Regulation Type: Regular notification
Protection of Stratospheric Ozone: Adjustments to the Allowance System for Controlling HCFC Production and Import, 2020-2029; and Other Updates
Distribution date: 20 March 2020 | Final date for Comment: 10 May 2025
Final Rule - The U.S. Environmental Protection Agency is allocating production and consumption allowances for specific hydrochlorofluorocarbons, a type of ozone-depleting substance, for the years 2020 through 2029. These hydrochlorofluorocarbons may be used to service certain equipment manufactured before 2020. The EPA is also updating other requirements under the program for controlling production and consumption of ozone-depleting substances, as well as making edits to the regulatory text for improved readability and clarity. These updates include revising the labeling requirements for containers of specific hydrochlorofluorocarbons; prohibiting the transfer of hydrochlorofluorocarbon allowances allocated through this rulemaking into allowances for hydrochlorofluorocarbons that have already been phased out; requiring the use of an electronic reporting system for producers, importers, exporters, transformers, and destroyers of controlled ozone-depleting substances; revising and removing recordkeeping and reporting requirements; improving the process for petitioning to import used ozone-depleting substances for reuse, including by creating more flexibility for imports of used halon from certain halon banks and exempting imports of aircraft bottles containing halon 1211 for hydrostatic testing from the petition process; creating a certification process for importing both used and virgin ozone-depleting substances for destruction; and restricting the sale of known illegally imported substances. This rule includes clarifications to the certification requirements for methyl bromide quarantine and preshipment uses. The EPA is also adding polyurethane foam systems containing ozone-depleting chlorofluorocarbons to the list of nonessential products. Lastly, the Agency is updating the definition of "destruction" as used in the context of the production and consumption phaseout and removing obsolete provisions.
Products Covered: Hydrochlorofluorocarbon production and import
Regulation Type: Regular notification
Draft resolution number 782, 18 February 2020, regarding the active ingredient D11 - DICAMBA (dicamba) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE no. 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003
Distribution date: 20 March 2020 | Final date for Comment: 25 April 2020
This Draft resolution incorporates the following changes for the active ingredient D11 - DICAMBA (dicamba) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the corn culture with MRL of 0,05 mg/kg and safety security period "Not determined due to the modality of post-emergency use (application)";- includes the genetically modified corn culture with MRL of 0,05 mg/kg and safety security period of 70 days in tyhe modality of post-emergency use (application);- changes the MRL form 0,01 to 0,05 mg/kg of the corn culture in the modality of desiccant use (application);- includes the phrase: acceptable daily intake (ADI) of 0,3 mg/kg b.w. and acute reference dose (ARfD) of 0,5 mg/kg b.w.
Products Covered: HS Code(s): 1005; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 785, 19 February 2020, regarding the active ingredient A18 - ABAMECTINA (abamectin) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE no. 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003
Distribution date: 20 March 2020 | Final date for Comment: 25 April 2020
This Draft resolution incorporates the following changes for the active ingredient A18 - ABAMECTINA (abamectin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of billet treatment in the plantation furrows use (application):- includes the cane sugar culture with MRL of 0,005 mg/kg and safety security period "Not-determined due to the modality of use (application)".
Products Covered: HS Code(s): 170111; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 780, 18 February 2020, regarding the active ingredient A26 - AZOXISTROBINA (azoxystrobin) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE no. 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003
Distribution date: 20 March 2020 | Final date for Comment: 25 April 2020
This Draft resolution incorporates the following changes for the active ingredient A26 - AZOXISTROBINA (azoxystrobin) 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 lentil, chickpea, and caupi bean cultures with MRL of 0,1 mg/kg and safety security period of 7 days.
Products Covered: HS Code(s): 071340, 071320, 07133500; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 791, 9 March 2020, regarding the active ingredient M04 - MCPA (acetic acid) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE no. 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003
Distribution date: 20 March 2020 | Final date for Comment: 09 May 2020
This Draft resolution incorporates the following changes for the active ingredient M04 - MCPA (acetic acid) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of post-emergency use (application): - includes the soya culture with MRL of 0,05 mg/kg and safety security period "Not-determined".
Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 787, 9 March 2020, regarding the active ingredient C74 - CIANTRANILIPROLE (cyantraniliprole) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE no. 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003
Distribution date: 20 March 2020 | Final date for Comment: 09 May 2020
This Draft resolution incorporates the following changes for the active ingredient C74 - CIANTRANILIPROLE (cyantraniliprole) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers: - includes the apple culture with MRL of 0,06 mg/kg and safety security period of 14 days in the modality of foliar use (application);- changes the safety security period of the citrus culture from 21 to 7 days; - changes the MRL of the red pepper culture from 0,03 mg/kg to 0,15 mg/kg in all modalities of use (application);- changes the MRL of the tomato culture from 0,07 mg/kg to 0,1 mg/kg in all modalities of use (application);- includes the grape culture with MRL of 1,5 mg/kg and safety security period of 14 days in the modality of foliar use (application);- changes the safety security period of the soya culture from 28 days to 14 days in the modality of foliar use (application).
Products Covered: HS Code(s): 080810, 0805, 0904, 0702, 080540, 1201; ICS Code(s): 13, 65
Regulation Type: Regular notification
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