Regulatory Updates
Inmetro Ordinance No. 473, 29 November 2021
Distribution date: 07 December 2021
Inmetro Ordinance No. 473 consolidates the control of the liquid content for the quantitative indication of cosmetic and toilet products sold in nominal quantities of 5 g or mL to 20 g or mL.
Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Resolution – RDC number 301, 21 August 2019
Distribution date: 07 December 2021
Resolution – RDC number 301, 21 August 2019 - previously notified through G/TBT/N/BRA/870/Add.1 - which establishes Good Practice Guidelines for the Manufacture of Medicines, was changed Resolution – RDC number 580, 26 November 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6359266/RDC_580_2021_.pdf/e9498832-cfe6-43f3-b175-0986c6bc5d5c
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Robenidine.
Products Covered: - Meat and edible meat offal (HS Codes: 02.07 and 02.09) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Code: 15.01)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Trimethoprim.
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 and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Maduramicin.
Products Covered: - Meat and edible meat offal (HS Codes: 02.07 and 02.09) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Code: 15.01)
Regulation Type: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Tylvalosin.
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
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Feed Additives: Canthaxanthin.
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
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Oxyclozanide.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.04, 02.05, 02.06 and 02.08) - Dairy produce (HS Code: 04.01) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Codes: 15.02 and 15.06)
Regulation Type: Regular notification
Normative Instruction number 100, 23 August 2021.
Distribution date: 06 December 2021
The Normative Instruction number 100, 23 August 2021 – previously notified through G/TBT/N/BRA/707/Add.4– which establishes the drugs subject to the National Drug Control System (SNCM) and deadlines for serialization and for starting the communication of records of instances of events, was changed by the Normative Instruction number 108, 25 November 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/2724161/IN_108_2021_.pdf/3297ccfb-433d-4f72-b8e0-59668c8eecf6
Products Covered: Medicines
Regulation Type: Addendum to Regular Notification
Normative Instruction number 35, 21 August 2019
Distribution date: 06 December 2021
The Normative Instruction number 35, 21 August 2019 - previously notified through G/TBT/N/BRA/870/Add.2- which establishes Complementary guidelines to the manufacture of sterile medicinal products, was changed by Normative Instruction number 109, 26 November 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6359266/IN_109_2021_.pdf/16c9c2d3-d346-4317-be12-301824a95a5b
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
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