Regulatory Updates
Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program
Distribution date: 15 June 2020 | Final date for Comment: 27 July 2020
Notice of proposed rulemaking - Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action proposes to list certain substances in the refrigeration and air conditioning sector and the foam blowing sector. For the retail food refrigeration-- medium-temperature stand-alone units (new) end-use, EPA is proposing to list substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is proposing to list substitutes as acceptable subject to use conditions. For the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, EPA is proposing to list substitutes as acceptable. This action also proposes to remove an acceptable subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions.
Products Covered: Chemical substances
Regulation Type: Regular notification
Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program
Distribution date: 15 June 2020 | Final date for Comment: 27 July 2020
Notice of proposed rulemaking - Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action proposes to list certain substances in the refrigeration and air conditioning sector and the foam blowing sector. For the retail food refrigeration-- medium-temperature stand-alone units (new) end-use, EPA is proposing to list substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is proposing to list substitutes as acceptable subject to use conditions. For the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, EPA is proposing to list substitutes as acceptable. This action also proposes to remove an acceptable subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions.
Products Covered: Chemical substances
Regulation Type: Regular notification
The Resolution – RDC number 356, 23 March 2020 – previously notified through G/TBT/N/BRA/993 – which establishes exceptional criteria and procedure for the manufacturing, import, and acquisition of medical devices identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was changed by the Resolution – RDC number 379, 30 April 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 12 June 2020
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 356, 23 March 2020 – previously notified through G/TBT/N/BRA/993 – which establishes exceptional criteria and procedure for the manufacturing, import, and acquisition of medical devices identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was changed by the Resolution – RDC number 379, 30 April 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 12 June 2020
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
Resolution – RDC number 375, 17 April 2020
Distribution date: 11 June 2020
This resolution extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV identified as essential to healthcare services, due to the international public health emergency related to the SARS-CoV-2.
Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
Resolution – RDC number 375, 17 April 2020
Distribution date: 11 June 2020
This resolution extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV identified as essential to healthcare services, due to the international public health emergency related to the SARS-CoV-2.
Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
Resolution – RDC number 378, 28 April 2020
Distribution date: 11 June 2020
This resolution extraordinarily and temporarily establishes technical requirements for the import, marketing, and donation of lung ventilators, vital signs monitor, infusion pump sets, oximetry machine, and used capnographs, indispensable for intensive care units, due to the international public health emergency related to the Covid-19.
Products Covered: HS Code(s): Medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
Resolution – RDC number 378, 28 April 2020
Distribution date: 11 June 2020
This resolution extraordinarily and temporarily establishes technical requirements for the import, marketing, and donation of lung ventilators, vital signs monitor, infusion pump sets, oximetry machine, and used capnographs, indispensable for intensive care units, due to the international public health emergency related to the Covid-19.
Products Covered: HS Code(s): Medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)
Regulation Type: Regular notification
Draft Resolution number 812, 12 May 2020 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56188
Distribution date: 11 June 2020 | Final date for Comment: 10 July 2020
This draft resolution changes the Resolution – RDC number 73, 7 April 2016, which establishes technical requirements for post-registration changes and cancellation procedures for registering medicines.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
Draft Resolution number 812, 12 May 2020 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=56188
Distribution date: 11 June 2020 | Final date for Comment: 10 July 2020
This draft resolution changes the Resolution – RDC number 73, 7 April 2016, which establishes technical requirements for post-registration changes and cancellation procedures for registering medicines.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
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