Regulatory Updates

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-KS-7/8093 as of 17 March 2020

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Distribution date: 30 March 2020

This letter introduces a temporary restriction on import of life poultry and poultry products mentioned in point 3 from Poland (Silesian and Łódź Voivodeships) due to the outbreak of highly pathogenic avian influenza.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, daily chicks, incubation egg of poultry, incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds HS Codes: 0105; 0407, 0408; 0207;0208,0209,0210,0410 00 000 0,0504 00 000 0,0505,0511,1501,1506 00 000 0,1516 10,1518 00,1601 00,1602, 1603 00,1902 20,1904 20,products from group 20, from 2104, from 2106, 4206 00 000 0, 0106; 508 10 000 0,0106,9705 00 000 0; 9508 10 000 0,0106; 2102, 2309, 2936, 3504, 3507, 3808, 3824; 3923,3926,4415 4416 00 000 0, 4421, 7020 00, 7309 00, 7310, 7326, 7616, 8436 10 000 0, 8436 21 000 0, 8436 29 000 0, 8436 80 900 0, 8606 91 800 0, 8609 00, 8716 39 800

Regulation Type: Emergency notifications (SPS)

Avian Influenza Animal diseases Food safety Animal health Human health Pest- or Disease- free Regions / Regionalization Zoonoses

Resolution – RDC number 349, 19 March 2020

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Distribution date: 26 March 2020

This Resolution establishes extraordinary and temporary criteria and procedure for the handling of petitions for the market authorization of individual protection equipment, lung ventilator equipment, and another medical devices identified as strategic by Anvisa, due to the international public health emergency of the new coronavirus (Covid-19).

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006, 63079090, 90192090 (medical devices, protection equipment, and lung ventilator)

Regulation Type: Regular notification

E09. COVID-19 TBT

Resolution – RDC number 350, 19 March 2020

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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

E09. COVID-19 TBT

Resolution – RDC number 348, 17 March 2020

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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

E09. COVID-19 TBT

Laundry detergents - Compulsory requirements

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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:

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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.

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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

Human health Food additives Food safety Packaging

DUS 2229-1:2020, Surgical gauze — Specification — Part 1: Absorbent, First edition

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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

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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

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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

Maximum residue limits (MRLs) Food safety Human health Pesticides

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