Regulatory Updates

Distribution date: 18 May 2021

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 2229-2:2020, Surgical gauze - Specification - Part 2: Petrolatum, First edition; notified in G/TBT/N/UGA/1217 was adopted on 2 March 2021. The Uganda Standard, US 2229-2:2020, Surgical gauze - Specification - Part 2: Petrolatum, First edition, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Petrolatum gauze

Regulation Type: Addendum to Regular Notification

Distribution date: 18 May 2021 | Final date for Comment: 17 July 2021

This Draft Uganda Standard specifies requirements, sampling and test methods for water based undercoat used on buildings after surface preparation and priming wherever necessary.

Products Covered: Paints and varnishes based, incl. enamels and lacquers, on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous medium, and solutions of products of headings 3901 to 3913 in volatile organic solvents, containing > 50% solvent by weight (excl. those based on polyesters and acrylic or vinyl polymers and solutions of collodion) (HS code(s): 320890); Paints and varnishes (ICS code(s): 87.040)

Regulation Type: Regular notification

Distribution date: 18 May 2021 | Final date for Comment: 17 July 2021

This Draft Uganda Standard specifies requirements, methods of sampling and test for two-pack epoxy zinc phosphate weldable primer. This material is used as a base coat for the painting of steel structures /equipment where corrosion protection and chemical resistance under marine atmospheric conditions are required, First Edition.

Products Covered: Epoxy zinc phosphate weldable primer

Regulation Type: Regular notification

Distribution date: 17 May 2021

ANVISA Resolution number 483, 19 March 2021- previously notified through  G/TBT/N/BRA/1154 - which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2. , was changed by Resolution – RDC  number 496, 11 May 2021.   The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6245812/RDC_496_2021_.pdf/70d5b5d6-5381-4ddf-9c2d-1828dc094d6e

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis, incl. natural concentrates, derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent (HS code(s): 2936); Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof "incl. chain modified polypeptides", used primarily as hormones (HS code(s): 2937); Antibiotics (HS code(s): 2941); PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 17 May 2021

This addendum aims to inform that the National Institute of Metrology, Quality and Technology – INMETRO, issued a rectification Inmetro Ordinance N° 206, 4 May 2021, published in the Brazilian Official Gazette on 5 May 2021, section 1, page 72 – previously notified through G/TBT/N/BRA/1174 – where it reads: "Metrological Technical Regulation - RTM established by Ordinance 205, 04 May 2021.", should read: "Metrological Technical Regulation - RTM established by Ordinance 206, 04 May 2021."

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 12 May 2021

This Ordinance approves the Metrological Technical Regulation that establishes the criteria for verifying the liquid content of the insecticide or liquid repellent product commercialize in a container to be coupled to an electrical device – Consolidated.

Products Covered: Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Insecticides (ICS code(s): 65.100.10)

Regulation Type: Regular notification

Distribution date: 11 May 2021

The Normative Instruction number 51, 19 December 2019 - previously notified through G/SPS/N/BRA/1527/Add.2 - which establishes Maximum Residue Limit (MRL), Acceptable Daily Intake (ADI), and Acute Reference Dose (ARfD) of Active Pharmaceutical Ingredient (API) for veterinary drugs in food of animal origin, was changed by the Normative Instruction number 89, 8 April 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6257261/IN_89_2021_.pdf/8c7c3a2a-133c-45bf-b246-3b60f4c15d2f.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2021

The Draft Resolution number 1005, 27 January 2021 - previously notified through G/SPS/N/BRA/1894 - was adopted as Resolution - RE number 1422, 8 April 2021.The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=12/04/2021&jornal=515&pagina=130.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2021

The Draft Resolution number 1006, 27 January 2021 - previously notified through G/SPS/N/BRA/1895 - was adopted as Resolution - RE number 1423, 8 April 2021.The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=12/04/2021&jornal=515&pagina=130.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2021 | Final date for Comment: 20 June 2021

This Draft resolution incorporates the following changes for the active ingredient Q05.1 - QUIZALOFOPE-P-ETÍLICO (quizalofop-P) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the phrase at item "h": Acceptable Daily Intake (ADI): 0,009 mg/kg b.w. (source: EFSA*, 2009);- includes the phrase at item "i": Acute Reference Dose (ARfD): Not applicable (source: EFSA*, 2009);- includes the phrase at item "j": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the sum of the active ingredient quizalofop, its salts, esters (including propaquizafop), and conjugateds, expressed as quizalofop";- includes the phrase: "*European Food Safety Authority".This Draft resolution incorporates the following changes for the active ingredient Q05.2 - QUIZALOFOPE-P-TEFURÍLICO (quizalofop-P) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the phrase at item "h": Acceptable Daily Intake (ADI): 0,013 mg/kg b.w. (source: EFSA*, 2008);- includes the phrase at item "i": Acute Reference Dose (ARfD): 0,1 mg/kg b.w. (source: EFSA*, 2008);- includes the phrase at item "j": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the sum of the active ingredient quizalofop, its salts, esters (including propaquizafop), and conjugateds, expressed as quizalofop";- includes the phrase: "*European Food Safety Authority".

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification