Distribution date: 10 March 2023

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Dipropyl isocinchomeronate.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06) 

Regulation Type: Regular notification

Distribution date: 10 March 2023

Proposed maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Pyridachlometyl.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.07, 07.09 and 07.10)Edible fruit and nuts (HS codes: 08.07, 08.10 and 08.11)Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 10 March 2023

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Pyrimethamine.

Products Covered: Meat and edible meat offal (HS codes: 02.03, 02.06, 02.07 and 02.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.01) 

Regulation Type: Regular notification

Distribution date: 10 March 2023

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Metobromuron.

Products Covered: Edible vegetables and certain roots and tubers (HS codes: 07.01 and 07.13)Cereals (HS code: 10.01) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS code: 12.01) 

Regulation Type: Regular notification

Distribution date: 10 March 2023

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Mafoprazine.

Products Covered: Meat and edible meat offal (HS codes: 02.03, 02.06 and 02.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.01)      

Regulation Type: Regular notification

Distribution date: 10 March 2023

Proposed maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Diminazene.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02 and 02.06)Dairy produce (HS code: 04.01)Animal originated products (HS code: 05.04)Animal fats and oils (HS code: 15.02)

Regulation Type: Regular notification

Distribution date: 09 March 2023

The Resolution – RDC number 646, 24 March 2022 – previously notified through G/TBT/N/BRA/1341 – Which contains provisions on the obligation to describe the composition in Portuguese on the labelling of personal hygiene products, cosmetics and perfumes, was modified  by  Resolution – RDC number 773, 15 February 2023.   The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6555105/RDC_773_2023_.pdf/e7497be6-fcfe-42da-9222-4afea0fc8c66 

Products Covered: HS (3303, 3304, 3305, 3306, 3307) - Toiletries, cosmetics and perfumes

Regulation Type: Addendum to Regular Notification

Distribution date: 09 March 2023 | Final date for Comment: 05 May 2023

The Draft resolution number 1136, 26 December 2022, previously notified through G/TBT/N/BRA/1467 - which regards a proposal to define the general guidelines for the pilot implementation of the optimized analysis procedure, based on risk criteria, to confirm the suitability of the documentation submitted to Anvisa for marketing authorization and post-marketing authorization changes to medicines, had its period for comments extended for 60 days by Order number 27, from 06 March 2023. The final text is available only in Portuguese and can be downloaded at:  https://www.in.gov.br/en/web/dou/-/despacho-n-27-de-06-de-marco-de-2023-468130483 

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 March 2023 | Final date for Comment: 05 April 2023

The Draft Resolution number 1.137, of 27 December 2022 - previously notified through G/TBT/N/BRA/1466 - which contains provisions on rules for preparing, harmonizing, updating, publishing and making available drug inserts for patients and health professionals, had its period for comments extended by 30 days through Order Number 25, from  6 March 2023. The final text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/despacho-n-25-de-6-de-marco-de-2023-468130801

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 09 March 2023

The Draft resolution number 730, 14 October 2019 (previously notified through G/TBT/N/BRA/928), which proposes the updating of the Resolution – RDC number 185, 22 October 2001, which establishes the risk classification, market authorization and technical requirements for labelling and usage instructions of medical devices, was adopted as Resolution - RDC number 751, 15 September 2022.  Resolution - RDC number 751, 15 September 2022, which provides for risk classification, reporting and registration regimes, and labeling requirements and instructions for use of medical devices, was now modified by Resolution - RDC number 777, 1st March 2023. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/5672055/RDC_777_2023_.pdf/de9823a6-80e9-427b-926f-d9651078fcea 

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

Regulation Type: Addendum to Regular Notification