Resolution – RDC number 350, 19 March 2020

Distribution date: 26 March 2020
This resolution establishes exceptional criteria and procedure for the manufacturing and sale of antiseptic preparations and sanitizers without previous market authorization from Anvisa and provides other measures due to the international public health emergency related to the SARS-CoV-2.
Products Covered: HS Code(s): 33079090, 38089990, 3402 (antiseptic preparations, sanitizer)
Regulation Type: Regular notification
Resolution – RDC number 348, 17 March 2020

Distribution date: 26 March 2020
This resolution establishes exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products; and for the post-market authorization of medicines and biological products due to the international public health emergency of the new coronavirus (Covid-19).
Products Covered: HS Code(s): 2941; 3002300; 3003; 3004; 3005; (pharmaceutical products, in vitro diagnosis products, biological products).
Regulation Type: Regular notification
Laundry detergents - Compulsory requirements

Distribution date: 26 March 2020 | Final date for Comment: 25 May 2020
This standard establishes compulsory requirements for laundry detergents. It specifies the chemical requirements for key parameters and also includes requirements for labelling of the packaging used for laundry detergents. This national standard is applicable to laundry detergent that is intended primarily for washing textile products using washing machines designed for household applications or by manual means. The requirements apply to laundry detergents in the following forms : powder; liquid; bar; and liquid laundry detergent packet, capsule or pod. This standard does not apply to detergents for washing and cleaning outside the domestic sphere, carried out by specialised personnel using specific products.
Products Covered: (HS code(s): 340290); Surface active agents (ICS code(s): 71.100.40)
Regulation Type: Regular notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products 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: 25 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Those foods, food additives, food utensils, food containers or packaging classified under 4 specific CCC codes.

Distribution date: 24 March 2020 | Final date for Comment: 23 May 2020
Commodities classified under four specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for foods, food additives, food utensils, food containers or packaging. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.
Products Covered: Foods, food additives, food utensils, food containers or packaging
Regulation Type: Regular notification
DUS 2229-1:2020, Surgical gauze — Specification — Part 1: Absorbent, First edition

Distribution date: 23 March 2020 | Final date for Comment: 22 May 2020
This Draft Uganda standard specifies the requirements, methods of test and sampling of absorbent gauze.
Products Covered: Absorbent gauze
Regulation Type: Regular notification
DUS 2235:2019, Plaster of Paris bandage — Specification, First edition

Distribution date: 23 March 2020 | Final date for Comment: 22 May 2020
This Draft Uganda standard specifies the requirements, methods of test and sampling of plaster of Paris (POP) bandage.
Products Covered: Plaster of Paris bandage
Regulation Type: Regular notification
Draft resolution number 781, 18 February 2020, regarding the active ingredient D39 - DIMETOMORFE (dimethomorph) 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 D39 - DIMETOMORFE (dimethomorph) 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 chard, chicory, stevia reubadiana and mustard cultures with MRL of 2,0 mg/kg and safety security period of 7 days;- includes the shallot culture with MRL of 0,2 mg/kg and safety security period of 14 days;- includes the pineapple, soursop, cupuacu and kiwi cultures with MRL of 0,7 mg/kg and safety security period of 7 days; - includes the gherkin culture with MRL of 0,1 mg/kg and safety security period of 7 days;- includes the okra culture with MRL of 0,2 mg/kg and safety security period of 7 days;- includes plants for ornamental purposes: alstroemeria, alyssum, amaryllis, azalea, snapdragon, Indian shot, carnation, celosia, coleus forskohlii, euonymus, ruscus, pittosporum, gardenia, geranium, gerberas, gladiolus, hydrangea, lantana, lisianthus, lily, daisy, sage, sedum makinoi, verbena, vinca, and zinnia with MRL and safety security period of "Non-food use".
Products Covered: HS Code(s): 07052, 120750, 0703, 080430, 071140, 0603, 0604, 06, 12099110, 12119029, 07099990, 081090, 08105000, cupuacu; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 788, 9 March 2020, regarding the active ingredient D36 - DIFENOCONAZOL (difenoconazole) 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: 19 May 2020
This Draft resolution incorporates the following changes for the active ingredient D36 - DIFENOCONAZOL (difenoconazole) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers: - includes the lentil, chickpea, and caupi bean cultures with MRL of 0,08 mg/kg and safety security period of 14 days in the modality of foliar use (application);- changes the safety security period of the ground-nut culture from 22 to 14 days in the modality of foliar use (application);- changes the MRL of the bean culture from 0,03 to 0,08 mg/kg.
Products Covered: HS Code(s): 071340, 071320, 200811, 070820, 07133500; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 790, 9 March 2020, regarding the active ingredient P50 - PICOXISTROBINA (picoxystrobin) 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 P50 - PICOXISTROBINA (picoxystrobin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - changes the MRL of the soya culture from 0,02 to 0,04 mg/kg.
Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65
Regulation Type: Regular notification
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