Resolution – RDC number 476, 10 March 2021.

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Distribution date: 19 March 2021 | Final date for Comment: 13 May 2025

This resolution establishes the procedure and technical requirements for the submission of temporary and exceptional market authorization application for the import and distribution of medicines and vaccines for Covid-19 to tackle the national public health emergency related to the outbreak of the new coronavirus (SARS-CoV-2) in accordance with the Law number 14.124, 10 March 2021.

Products Covered: Antibiotics (HS code(s): 2941); Vaccines for human medicine (HS code(s): 300220); 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 for 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); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

E09. COVID-19 TBT

Resolution – RDC number 475, 10 March 2021.

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Distribution date: 19 March 2021 | Final date for Comment: 13 May 2025

This resolution establishes the procedure and technical requirements for the application for temporary market authorization on an emergency basis of medicines and vaccines for Covid-19 in experimental character to tackle the national public health emergency related to the outbreak of the new coronavirus (SARS-CoV-2)

Products Covered: 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 for 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); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

E09. COVID-19 TBT

Draft Eurasian Economic Commission Council Decision on amendments to the Common List of Goods Subject to Veterinary Control (surveillance) and Draft Eurasian Economic Commission Collegium Decision on amendments to the Regulation on Common veterinary (sanitary and veterinary) requirements for goods subject to veterinary control (surveillance)

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Distribution date: 22 March 2021 | Final date for Comment: 21 May 2021

The drafts provide for expansion of the list of goods subject to veterinary control on goods from HS Code 3823 of the EAEU Commodity Nomenclature of Foreign Economic Activity, as well as specification of veterinary measures applied for goods from HS code 3823 of EAEU CN of FEA.

Products Covered: Feed additives (HS Code: from 3823)

Regulation Type: Regular notification

Animal feed Animal health Feed additives

Draft Eurasian Economic Commission Council Decision on amendments to the Common List of Goods Subject to Veterinary Control (surveillance) and Draft Eurasian Economic Commission Collegium Decision on amendments to the Regulation on Common veterinary (sanitary and veterinary) requirements for goods subject to veterinary control (surveillance)

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Distribution date: 22 March 2021 | Final date for Comment: 21 May 2021

The drafts provide for expansion of the list of goods subject to veterinary control on goods from HS Code 3823 of the EAEU Commodity Nomenclature of Foreign Economic Activity, as well as specification of veterinary measures applied for goods from HS code 3823 of EAEU CN of FEA.

Products Covered: Feed additives (HS Code: from 3823)

Regulation Type: Regular notification

Animal feed Animal health Feed additives

Protection of the Stratospheric Ozone: Motor Vehicle Air Conditioning System Servicing

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Distribution date: 25 March 2021 | Final date for Comment: 13 May 2025

Protection of the Stratospheric Ozone: Motor Vehicle Air Conditioning System Servicing AGENCY: Environmental Protection Agency (EPA) ACTION: Final rule SUMMARY: The Environmental Protection Agency (EPA) is adopting three technical standards developed by SAE International (SAE) for equipment that recovers, recycles, and/or recharges the refrigerant 2,3,3,3- Tetrafluoroprop-1-ene (HFO-1234yf or R-1234yf) in motor vehicle air conditioners (MVACs). The three standards are SAE J2843, SAE J2851, and SAE J3030. This rule adopts the most current versions of these standards by incorporating them by reference into the regulations under Title VI of the Clean Air Act (CAA). This will provide additional flexibility for industry stakeholders that wish to select recovery and recycling equipment certified to these standards. DATES: This final rule is effective on 23 April 2021, 30 days after publication in the Federal Register. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of 23 April 2021. This final rule and the notice of proposed rulemaking notified as G/TBT/N/USA/1594 are identified by Docket Number EPA-HQ-OAR-2013-0597. The Docket Folder is available at https://www.regulations.gov/docket/EPA-HQ-OAR-2013-0597/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.

Products Covered: Motor vehicle refrigerant

Regulation Type: Addendum to Regular Notification

Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of temporary restrictions on the importation into the territory of Kazakhstan from Trnava region of the Slovak Republic, as well as transit from these territories through the territory of Kazakhstan of live birds, hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (not less than 70°C), feed and feed additives for poultry (except for feed additives of chemical and microbiological synthesis), trophies of the chase that have not undergone taxidermy treatment (feather game), as well as used equipment for keeping, slaughtering and cutting birds

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Distribution date: 26 March 2021 | Final date for Comment: 13 May 2025

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports an outbreak of highly pathogenic avian influenza in the territory of Trnava region of the Slovak Republic. In this regard, since 2 February 2021, temporary restrictions have been introduced on the importation into the territory of Kazakhstan from Trnava region of the Slovak Republic, as well as transit from these territories through the territory of Kazakhstan of live birds, hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (not less than 70°C), feed and feed additives for poultry (except for feed additives of chemical and microbiological synthesis), trophies of the chase that have not undergone taxidermy treatment (feather game), as well as used equipment for keeping, slaughtering and cutting birds.

Products Covered: Live poultry, hatching eggs, down and feathers, poultry meat and all poultry products, fodder and feed additives for birds, trophies of the chase, used for the maintenance, slaughter and cutting of birds

Regulation Type: Emergency notifications (SPS)

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

Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of the Republic of Kazakhstan on lifting the temporary restriction on the importation and transit to the territory of the Republic of Kazakhstan live birds and hatching eggs, down and feathers, poultry meat and all poultry products, feed and feed additives for birds, hunting trophies that have not undergone taxidermic treatment (feathered game), as well as used equipment for keeping, slaughter and cutting of birds from Vinnytsia Oblast of Ukraine

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Distribution date: 26 March 2021 | Final date for Comment: 13 May 2025

Kazakhstan notified in G/SPS/N/KAZ/65 (3 March 2020) and G/SPS/N/KAZ/66 (3 March 2020) the Letters of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan on the introduction of temporary restriction on the importation to the territory of Kazakhstan from Vinnytsia Oblast of Ukraine and transit through Vinnytsia Oblast of Ukraine to the territory of Kazakhstan of live birds and hatching eggs, down and feathers, poultry meat and all poultry products, that not heat treated, feed and feed additives for birds (except feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermic treatment (feathered game), as well as used equipment for keeping, slaughter and cutting of birds. The notified measure was modified by the Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan.

Products Covered:

Regulation Type: Addendum to Emergency Notification (SPS)

Avian Influenza Feed additives Withdrawal of the measure Zoonoses Animal feed Animal health Human health Pest- or Disease- free Regions / Regionalization Animal diseases Food safety

Draft resolution number 1026, 11 March 2021, regarding the active ingredient M17 - METOMIL (methomyl) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 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: 26 March 2021 | Final date for Comment: 15 May 2021

This Draft resolution incorporates the following changes for the active ingredient M17 - METOMIL (methomyl) 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 avocado, cocoa, cupuacu, guarana, kiwi, papaya, mango, passion fruit, melon, watermelon, and pomegranate cultures with MRL of 0.01 mg/kg and safety security period of 14 days;- includes the acerola, blackberry, raspberry, blueberry, strawberry, and Brazilian cherry cultures with MRL of 0.015 mg/kg and safety security period of 14 days;- includes the phrase at item "k": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient methomyl".

Products Covered: HS Code(s): 18, 0804, 081090, 0807, 081020, 081040, 081010, 3295, 08105000, 08109090, 080920, 081190, cupuacu; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution number 1021, 11 March 2021, regarding the active ingredient P61 - PIROXASULFONA of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 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: 26 March 2021 | Final date for Comment: 15 May 2021

This Draft resolution incorporates the following changes for the active ingredient P61 - PIROXASULFONA from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of pre emergency use (application):- includes the groundnut, potato, barley, and sunflower cultures with MRL of 0.02 mg/kg and safety security period "Not determined due to the modality of use (application)";- includes the tobacco culture with MRL and safety security period of "Non-food use".

Products Covered: HS Code(s): 24, 1003, 1202, 1206, 0701; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Maximum residue limits (MRLs) Human health Pesticides

Draft resolution number 1023, 11 March 2021, regarding the active ingredient L05 - LUFENUROM (lufenuron) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 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: 26 March 2021 | Final date for Comment: 15 May 2021

This Draft resolution incorporates the following changes for the active ingredient L05 - LUFENUROM (lufenuron) 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 safety security period of the cotton culture from 28 to 14 days;- changes the safety security period of the bean culture from 21 to 7 days;- changes the safety security period of the corn culture from 35 to 28 days;- changes the safety security period of the soya culture from 35 to 21 days.

Products Covered: HS Code(s): 52, 1005, 1201, 07133; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

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