Resolution - RDC number 436, 5 November 2020

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Distribution date: 17 November 2020 | Final date for Comment: 16 May 2025

The Resolution - RDC number 428, 7 October 2020 - previously notified through G/SPS/N/BRA/1788 - which 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, was changed by the Resolution - RDC number 436, 5 November 2020. This regulation will be also notified to the TBT committee.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6053710/RDC_436_2020_.pdf/b36028dd-b15a-4f6a-97d9-4b90a337cdac

Products Covered:

Regulation Type: Addendum to Regular Notification

Maximum residue limits (MRLs) Modification of content/scope of regulation Food safety Human health Pesticides

Partial amendment to the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostics Pharmaceutical Products.

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Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021

The Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostic Pharmaceutical Products will be amended to harmonize with the amended relevant international standard (ISO 13485).

Products Covered: In vitro Diagnostic Pharmaceutical Products (HS: 30). Medical Devices (HS: 90).

Regulation Type: Regular notification

Partial amendment to the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostics Pharmaceutical Products.

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Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021

The Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostic Pharmaceutical Products will be amended to harmonize with the amended relevant international standard (ISO 13485).

Products Covered: In vitro Diagnostic Pharmaceutical Products (HS: 30). Medical Devices (HS: 90).

Regulation Type: Regular notification

Specifications for Cosmetic Efficacy Claim Evaluation (Draft for Comments)

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Distribution date: 18 November 2020 | Final date for Comment: 17 January 2021

The specifications stipulate the basic technical requirements for cosmetic efficacy claim evaluation.

Products Covered: Cosmetics

Regulation Type: Regular notification

Specifications for Cosmetic Efficacy Claim Evaluation (Draft for Comments)

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Distribution date: 18 November 2020 | Final date for Comment: 17 January 2021

The specifications stipulate the basic technical requirements for cosmetic efficacy claim evaluation.

Products Covered: Cosmetics

Regulation Type: Regular notification

Specifications for Cosmetics Registration and Filing (Draft for Comments)

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Distribution date: 18 November 2020 | Final date for Comment: 17 January 2021

The specifications stipulate the registration and filing of cosmetic products.

Products Covered: Cosmetics

Regulation Type: Regular notification

Specifications for Cosmetics Registration and Filing (Draft for Comments)

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Distribution date: 18 November 2020 | Final date for Comment: 17 January 2021

The specifications stipulate the registration and filing of cosmetic products.

Products Covered: Cosmetics

Regulation Type: Regular notification

Specifications for Registration and filing of New Cosmetic Ingredients (Draft for Comments)

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Distribution date: 18 November 2020 | Final date for Comment: 17 January 2021

The specifications stipulate the registration and filing of new cosmetic ingredients.

Products Covered: Cosmetics

Regulation Type: Regular notification

Specifications for Registration and filing of New Cosmetic Ingredients (Draft for Comments)

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Distribution date: 18 November 2020 | Final date for Comment: 17 January 2021

The specifications stipulate the registration and filing of new cosmetic ingredients.

Products Covered: Cosmetics

Regulation Type: Regular notification

Provisions for the Supervision and Administration of Toothpaste (Draft for Comments)

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Distribution date: 18 November 2020 | Final date for Comment: 17 January 2021

The provisions stipulate the supervision and administration of toothpaste to protect the health rights and interests of consumers.

Products Covered: Cosmetics

Regulation Type: Regular notification

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