Distribution date: 23 June 2020 | Final date for Comment: 22 August 2020

This regulation requires organic fertilizers, biofertilizers and soil enhancers, either produced domestically or imported, to be registered after completing the following assessment:  A. Quality testing based on the requirements stated in: • related SNIs as applicable (e.g . SNI 8267:2016  Liquid chitosan as organic fertilizer- Quality and processing requirements and SNI 7763:2018, Solid organic fertilizers), OR• Minimum Technical Requirements as applicable B. Effectiveness testing based on methodology and reporting prescribed in the Regulation and Annex II. Quality and effectiveness testing are performed by an accredited testing institution or designated by Ministerial Decree. Certificates and / or Quality Assessment result reports are valid for 12 months from the time of issuance and are used as registration requirements.

Products Covered: 3101.00.10; 3101.00.92 and 3101.00.99

Regulation Type: Regular notification

Distribution date: 22 June 2020 | Final date for Comment: 21 August 2020

This draft regulation specifies the use restrictions and labeling requirements for the astaxanthin produced by genetically modified Escherichia coli strain Ast12 for food purposes.

Products Covered: Food ingredient to be used in food

Regulation Type: Regular notification

Distribution date: 23 June 2020 | Final date for Comment: 11 May 2025

Products Covered: Hazardous substances used in agriculture (Pesticides)

Regulation Type: Addendum to Regular Notification

Distribution date: 23 June 2020 | Final date for Comment: 11 May 2025

Products Covered: Hazardous substances used in agriculture (Pesticides)

Regulation Type: Addendum to Regular Notification

Distribution date: 24 June 2020 | Final date for Comment: 11 May 2025

The Draft Resolution number 797, 26 March 2020 - previously notified through G/SPS/N/BRA/1648 - was adopted as Resolution - RE number 1816, 4 June 2020. The final text is available only in Portuguese and can be downloaded at: http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=08/06/2020&jornal=515&pagina=91

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 24 June 2020 | Final date for Comment: 11 May 2025

The Draft Resolution number 797, 26 March 2020 - previously notified through G/SPS/N/BRA/1648 - was adopted as Resolution - RE number 1816, 4 June 2020. The final text is available only in Portuguese and can be downloaded at: http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=08/06/2020&jornal=515&pagina=91

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020

This draft resolution proposes the revision of Resolution – RDC no. 199, 26 October 2006, which establishes the simplified notification of medicines through electronic submitting.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020

This draft resolution proposes the revision of Resolution – RDC no. 199, 26 October 2006, which establishes the simplified notification of medicines through electronic submitting.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 26 June 2020 | Final date for Comment: 21 July 2020

This draft resolution establishes technical requirements for the inclusion and updating of notification and market authorization form, product image, instructions for use and labelling in the process of regularization of medical devices.

Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)

Regulation Type: Regular notification

Distribution date: 26 June 2020 | Final date for Comment: 21 July 2020

This draft resolution establishes technical requirements for the inclusion and updating of notification and market authorization form, product image, instructions for use and labelling in the process of regularization of medical devices.

Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)

Regulation Type: Regular notification