Distribution date: 02 October 2020 | Final date for Comment: 21 November 2020

This Draft resolution incorporates the following changes for the active ingredient F68 - FLUXAPIROXADE (Fluxapyroxad) 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 cocoa culture with MRL of 0,7 mg/kg and safety security period of 7 days;-includes acerola, blackberry, raspberry, olive, Brazilian cherry, purple mombin, blueberry, and strawberry cultures with MRL of 1,5 mg/kg and safety security period of 1 day;-includes the plum, loquat, quince, nectarine, peach, and pear cultures with MRL of 1,5 mg/kg and safety security period of 7 days;-includes the chard, watercress, witloof chicory, chicory, spinach, stevia reubadiana, mustard, arugula, and lettuce cultures with MRL of 7,0 mg/kg and safety security period of 5 days;-includes the phrase: "Acute Reference Dose (ARfD): 0,3 mg/kg b.w. (source: JMPR*, 2012)-includes the following phrase from item "j" to item "m": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the substances Fluxapyroxad and its metabolits 3- (difluoromethyl)-1-methyl-N-(3',4',5'- trifluoro[1,1'-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide (fluxapiroxade), 3-(difluoromethyl)-N-(3',4',5'-trifluorobiphenyl2-yl)-1H-pyrazole-4-carboxamide (M700F008) and 3-(difluoromethyl)-11(β-D-glucopyranosyl)-N-(3',4',5'-trifluorobiphenyl2-yl)-1Hpyrazole-4-carboxamide (M700F048), expressed as Fluxapyroxad".

Products Covered: HS Code(s): 18, 120750, 081020, 071120, 081040, 081010, 080940, 080820, 080930, 07052, 070970, 080920, 071430, 081190, 0810909002, 12099110, 070990, 12119029, 0709999000; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 05 October 2020 | Final date for Comment: 26 May 2025

The revision of the Mandatory Standard SI 4272 part 1, dealing oven cleaners and grease removers, to be replaced by SI 4272, was published on 3 September 2020 and will enter into force on 2 December 2020. Both the old standard (SI 4272 part 1, April 2006) and the newly revised standard (SI 4272, August 2020) will apply from entry into force for a period of three years. During this time, products may be tested according to the old or the new revised standard. All sections of the newly revised standard, SI 4272 (August 2020), will be mandatory except in section 2.2.9 the sentence starting with "the words 'Not for human consumption' " and ending with "at least 3 mm".

Products Covered: Oven cleaners and grease removers

Regulation Type: Addendum to Regular Notification

Distribution date: 05 October 2020 | Final date for Comment: 26 May 2025

The revision of the Mandatory Standard SI 4272 part 1, dealing oven cleaners and grease removers, to be replaced by SI 4272, was published on 3 September 2020 and will enter into force on 2 December 2020. Both the old standard (SI 4272 part 1, April 2006) and the newly revised standard (SI 4272, August 2020) will apply from entry into force for a period of three years. During this time, products may be tested according to the old or the new revised standard. All sections of the newly revised standard, SI 4272 (August 2020), will be mandatory except in section 2.2.9 the sentence starting with "the words 'Not for human consumption' " and ending with "at least 3 mm".

Products Covered: Oven cleaners and grease removers

Regulation Type: Addendum to Regular Notification

Distribution date: 05 October 2020 | Final date for Comment: 16 October 2020

This Draft Resolution establishes the market authorization, inclusion and revising of the housecleaning use for the active ingredients A20 – AZAMETIFÓS, C82 – COLECALCIFEROL, D06 – DELAMETRINA, D13 – DICLORVÓS, D55 – DINOTEFURAN, M50 – MONFLUOROTRINA, and T48 – TIAMETOXAM. 

Products Covered: HS 340119

Regulation Type: Regular notification

Distribution date: 05 October 2020 | Final date for Comment: 16 October 2020

This Draft Resolution establishes the market authorization, inclusion and revising of the housecleaning use for the active ingredients A20 – AZAMETIFÓS, C82 – COLECALCIFEROL, D06 – DELAMETRINA, D13 – DICLORVÓS, D55 – DINOTEFURAN, M50 – MONFLUOROTRINA, and T48 – TIAMETOXAM. 

Products Covered: HS 340119

Regulation Type: Regular notification

Distribution date: 06 October 2020 | Final date for Comment: 26 May 2025

This Resolution changes the Resolution – RDC number 27, 21 June 2011, the Resolution – RDC number 36, 26 August 2015, and the Resolution – RDC number 40, 26 August 2015; and establishes the cancellation of the registration system for medical devices classified as Risk I and II classes, which must be registered in the notification regime.

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 06 October 2020 | Final date for Comment: 26 May 2025

This Resolution changes the Resolution – RDC number 27, 21 June 2011, the Resolution – RDC number 36, 26 August 2015, and the Resolution – RDC number 40, 26 August 2015; and establishes the cancellation of the registration system for medical devices classified as Risk I and II classes, which must be registered in the notification regime.

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 07 October 2020 | Final date for Comment: 26 May 2025

The Draft Resolution number 865, 7 July 2020 - previously notified through G/SPS/N/BRA/1732 - was adopted as Resolution - RE number 3847, 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=579

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 07 October 2020 | Final date for Comment: 26 May 2025

The Draft Resolution number 865, 7 July 2020 - previously notified through G/SPS/N/BRA/1732 - was adopted as Resolution - RE number 3847, 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=579

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 09 October 2020 | Final date for Comment: 08 December 2020

The notified draft regulations implementing Law No. 27645 regulating the marketing of methyl alcohol and Law No. 28317 on the control and monitoring of the marketing of methyl alcohol seek to establish the regulatory provisions for both laws. The draft regulations set out specifications and procedures for controlling and monitoring the marketing of methyl alcohol from the time of its manufacture or entry into the country through to when it reaches its final destination, with a view to preventing this type of product, which is harmful to health, from being diverted towards unlawful and informal activities, such as the production of alcoholic beverages containing methyl alcohol.

Products Covered: Methanol "methyl alcohol" (HS code(s): 290511); Alcohols. Ethers (ICS code(s): 71.080.60)

Regulation Type: Regular notification