Distribution date: 14 September 2022 | Final date for Comment: 04 May 2025

The proposal notified in G/SPS/N/EU/491 (26 May 2021) is now adopted by Commission Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Text with EEA relevance) [OJ L 151, 2 June 2022, p. 37]. This Regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.

Products Covered: Food supplements

Regulation Type: Addendum to Regular Notification

Distribution date: 14 September 2022 | Final date for Comment: 04 May 2025

This Resolution contains provisions on validation and permeability assays with Caco-2 cells.  

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 14 September 2022 | Final date for Comment: 04 May 2025

This Resolution establishes a temporary optimized analysis procedure, in which the analyzes conducted by an Equivalent Foreign Regulatory Authority are used for the verified analysis of the market authorization and post-market authorization petitions of medicines, biological products and their inputs, and the letter of adequacy of the pharmaceutical ingredient dossier active. This Resolution is valid for 180 (one hundred and eighty) days from the date of its entry into force.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 14 September 2022 | Final date for Comment: 13 December 2022

This Draft Resolution contains provisions on a proposed Normative Instruction that "Establishes the form of regularization of the different categories of food and packaging, and the respective documentation that must be presented" This regulation will be also notified to the SPS Committee. 

Products Covered:  FOOD TECHNOLOGY (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 14 September 2022 | Final date for Comment: 04 May 2025

The Public Consultation No. 1044, 8 April 2021 - previously notified through G/TBT/N/BRA/1165 - which establishes the criteria for the exemption and substitution of relative bioavailability and bioequivalence studies, was adopted as Resolution - RDC number 749, 05 September 2022  The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/2695968/RDC_749_2022_.pdf/d8c6877a-b162-49e8-944b-e1e88f7ef6ef   

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; (pharmaceutical products).

Regulation Type: Addendum to Regular Notification

Distribution date: 14 September 2022 | Final date for Comment: 13 November 2022

The document is to standardize the online cosmetics distribution and the service behavior on e-commerce platform of cosmetics to ensure the safety of consumers' health.

Products Covered:  Cosmetics (HS code(s): 33); (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 19 September 2022 | Final date for Comment: 04 May 2025

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 998:2019, Textured paints — Specification, First Edition; notified in G/TBT/N/UGA/1161 and G/TBT/N/UGA/1161/Add.1 entered into force on 14 May 2022. The Uganda Standard, US EAS 998:2021, Textured paints — Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Textured paints

Regulation Type: Addendum to Regular Notification

Distribution date: 19 September 2022 | Final date for Comment: 04 May 2025

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 127-1:2020; Synthetic detergent powders — Specification — Part 1: Household hand use, Second Edition; notified in G/TBT/N/UGA/1259 and G/TBT/N/UGA/1259/Add.1 entered into force on 14 May 2022. The Uganda Standard, US EAS 127-1:2021; Synthetic detergent powders — Specification — Part 1: Household hand use, Third Edition, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Synthetic detergent powders

Regulation Type: Addendum to Regular Notification

Distribution date: 19 September 2022 | Final date for Comment: 04 May 2025

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 849:2019, Silk (sheen) emulsion paint for interior use — Specification, Second Edition; notified in G/TBT/N/UGA/1159 and G/TBT/N/UGA/1159/Add.1 entered into force on 14 May 2022. The Uganda Standard, US EAS 849:2021, Silk (sheen) emulsion paint for interior use — Specification, Second Edition, Second Edition, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Silk (sheen) emulsion paint

Regulation Type: Addendum to Regular Notification

Distribution date: 19 September 2022 | Final date for Comment: 04 May 2025

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 937:2019, Semi-gloss (egg shell) solvent borne paints for interior and exterior use — Specification, First Edition; notified in G/TBT/N/UGA/1160 and G/TBT/N/UGA/1160/Add.1 entered into force on 14 May 2022. The Uganda Standard, US EAS 937:2021, Semi-gloss (egg shell) solvent borne paints for interior and exterior use — Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Semi-gloss (egg shell) solvent borne paints

Regulation Type: Addendum to Regular Notification