Distribution date: 14 January 2021 | Final date for Comment: 20 February 2021

This Draft resolution incorporates the following changes for the active ingredient C30 - CIFLUTRINA (cyfluthrin) 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 cotton culture from 0.01 to 0.1 mg/kg;- changes the MRL of the peanut culture from 0.01 to 0.1 mg/kg;- changes the MRL of the rice culture from 0.01 to 0.1 mg/kg;- changes the MRL of the coffe culture from 0.01 to 0.05 mg/kg;- changes the MRL of the bean culture from 0.01 to 0.1 mg/kg;- changes the MRL of the corn culture from 0.01 to 0.05 mg/kg;- changes the MRL of the soya culture from 0.01 to 0.1 mg/kg;- changes the MRL of the tomato culture from 0.02 to 0.2 mg/kg;- changes the MRL of the wheat culture from 0.01 to 0.05 mg/kg;- includes the phrase: "m) Acute Reference Dose (ARfD): 0.04 mg/kg b.w. (source: JMPR*, 2007);- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase: "n) for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient cyfluthrin and the sum of its isomers".

Products Covered: HS Code(s): 52, 1001, 1005, 1006, 1201, 1202, 20081, 09, 07133, 0701; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 14 January 2021 | Final date for Comment: 14 May 2025

The notified Regulation establishes the regulatory provisions of Article 8 of Law No. 29459 - Law on pharmaceutical products, medical devices and sanitary products, amended by Law No. 31091, to regulate the conditional sanitary registration of medicines and biological products with phase III clinical studies.

Products Covered: Pharmaceutical products classified under Chapter 30 of the Harmonized System or Customs Tariff

Regulation Type: Regular notification

Distribution date: 18 January 2021 | Final date for Comment: 14 May 2025

This letter introduces a temporary restriction on import of life poultry and poultry products from Lithuania due to the outbreak of highly pathogenic avian influenza.

Products Covered: Live poultry and hatching egg, poultry meat and poultry processed products not heat-treated, feeds and feed additives for poultry (with the exception of feed additives of vegetable origin, chemical and microbiological synthesis), used equipment and supplies for transportation, breeding, stockkeeping, slaughtering and cutting of poultry HS Codes: of 0105, of 0106, of 0207, of 0208, of 0209, of 0210, of 0407, of 0408, of 0410000000, of 0510000000, of 0504000000, of 0505, of 0507, of 1501, of 0511, of 150300, of 1506000000, of 151610, of 151800, of 160100, of 1602, of 160300, of 190220, of 190420, of 2104, of 2106, of 2309, of 2301, of 2309, of 3101000000, of 3502, of 350400, of 3507, of 4206000000, of 9508100000, of 9705000000

Regulation Type: Emergency notifications (SPS)

Distribution date: 18 January 2021 | Final date for Comment: 28 January 2021

This draft resolution changes the annex of Normative Instruction number 64, 27 July 2020 – previously notified through G/TBT/N/BRA/713/Add.1 –which establishes the list of active ingredients allowed in cosmetic products to modify the shape of the hair by changing its chemical structure and the requirements for its use.

Products Covered: Shaving preparations, incl. pre-shave and aftershave products, personal deodorants, bath and shower preparations, depilatories and other perfumery, toilet or cosmetic preparations, n.e.s.; prepared room deodorisers, whether or not perfumed or having disinfectant properties (HS code(s): 3307); Scent sprays and similar toilet sprays, and mounts and heads therefor; powder puffs and pads for the application of cosmetics or toilet preparations (HS code(s): 9616); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 18 January 2021 | Final date for Comment: 29 March 2021

This draft resolution establishes the guidelines for the risk assessment of exposure of operators, workers, residents, and bystanders to pesticides for the purpose of market authorization, post-market authorization alterations, reassessment, monitoring, and inspection procedures.

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Regular notification

Distribution date: 18 January 2021 | Final date for Comment: 12 February 2021

This draft resolution changes the Resolution – RDC number 47, 8 September 2009, which establishes technical requirements for the development, harmonization, updating, publication, and provision of medicine leaflets to patients and healthcare professionals. 

Products Covered: Antibiotics (HS code(s): 2941); 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 in the form of 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

Distribution date: 18 January 2021 | Final date for Comment: 28 January 2021

This draft resolution establishes the technical requirements for the use of lead acetate, pyrogallol, formaldehyde, and para formaldehyde in personal hygiene products, cosmetics, and perfumes

Products Covered: Perfumes and toilet waters (excl. aftershave lotions, personal deodorants and hair lotions) (HS code(s): 3303); Beauty or make-up preparations and preparations for the care of the skin, incl. sunscreen or suntan preparations (excl. medicaments); manicure or pedicure preparations (HS code(s): 3304); Preparations for use on the hair (HS code(s): 3305); Preparations for oral or dental hygiene, incl. denture fixative pastes and powders; yarn used to clean between the teeth "dental floss", in individual retail packages (HS code(s): 3306); Shaving preparations, incl. pre-shave and aftershave products, personal deodorants, bath and shower preparations, depilatories and other perfumery, toilet or cosmetic preparations, n.e.s.; prepared room deodorisers, whether or not perfumed or having disinfectant properties (HS code(s): 3307); Organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap (HS code(s): 340130); Scent sprays and similar toilet sprays, and mounts and heads therefor; powder puffs and pads for the application of cosmetics or toilet preparations (HS code(s): 9616); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 19 January 2021 | Final date for Comment: 26 February 2021

The final date for comments of the Draft Resolution number 932, 13 October 2020 – previously notified through G/TBT/N/BRA/1095 – which establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar, was extended for 30 days. 

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: Addendum to Regular Notification

Distribution date: 19 January 2021 | Final date for Comment: 26 February 2021

The final date for comments of the Draft Normative Instruction number 931, 13 October 2020 – previously notified through G/TBT/N/BRA/1094 – which establishes new codes for the administrative request of market authorization for new and innovative synthetic and semisynthetic medicines, was extended for 30 days. 

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: Addendum to Regular Notification

Distribution date: 19 January 2021 | Final date for Comment: 14 May 2025

The Draft Resolution number 704, 23 August 2019 – previously notified through G/TBT/N/BRA/909 – which is a complement for the revision of the Resolution – RDC number 64, 18 December 2009, which establishes the market authorization for radiopharmaceuticals, and proposes the documenting necessary for the protocol of market authorization for radiopharmaceuticals, was adopted as Normative Instruction number 80, 16 December 2020. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/3633045/IN_80_2020_.pdf/e1514ef7-c00d-485b-8c97-0cba2714df97

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Addendum to Regular Notification