Resolución 634 del 17 de junio de 2022 "Por la cual en desarrollo del Protocolo de Montreal, se entiende prohibida la fabricación e importación de equipos y productos que contengan y/o requieran para su operación o funcionamiento las sustancias controladas en los Anexos A, B, C, E y F del Protocolo de Montreal y se adoptan otras disposiciones" (Resolution No. 634 of 17 June 2022 "prohibiting, in accordance with the Montreal Protocol, the manufacture and importation of equipment and products that contain the controlled substances listed in Annexes A, B, C, E and F of the Montreal Protocol and/or that require those substances in order to be operational or to function, and adopting other provisions") (20 pages, in Spanish)

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Distribution date: 27 June 2022 | Final date for Comment: 04 May 2025

The notified Resolution establishes provisions applicable to all natural and legal persons that manufacture and/or import certain equipment and products, where these contain, have required for their production and/or require in order to be operational or to function, the controlled substances listed in Annexes A, B, C, E and F of the Montreal Protocol.

Products Covered: In accordance with the Montreal Protocol, the manufacture and importation of equipment and products containing the controlled substances listed in Annexes A, B, C, E and F of the Protocol and/or requiring those substances in order to be operational or to function, shall be prohibited in Colombia.

Regulation Type: Regular notification

D06. Treaties

Draft amendment of the Annexes 2, 3, 4 and 7 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance)

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Distribution date: 28 June 2022 | Final date for Comment: 15 July 2022

Annex 2: The technical regulations for the classification, labelling and packaging of substances and preparations will be updated and thus adapted to technical progress in the EU (18th ATP of the EU CLP Regulation; binding from 23 November 2023).This draft revision updates the list of harmonized classifications:inclusion of 39 substances;amendment of 17 existing entriesone existing entry is split up in twoWith this draft revision, the latest developments in test methods for substances and preparations (OECD) are adopted.  Annex 3: Four substances are included in the candidate list of substance of very high concern. This listing triggers information obligations along the supply chain.Annex 4 (Technical Dossier for Notifications): The requirements are updated in accordance with the specifications for registrations in the EU.Annex 7 (List of new substances for which notification is not required): Three entries are eliminated.

Products Covered: Inorganic chemicals; organic or inorganic compounds of precious metals, of rare- earth metals, of radioactive elements or of isotopes (HS code(s): 28); Organic chemicals (HS code(s): 29); Miscellaneous chemical products (HS code(s): 38); Protection against dangerous goods (ICS code(s): 13.300); CHEMICAL TECHNOLOGY (ICS code(s): 71); RUBBER AND PLASTIC INDUSTRIES (ICS code(s): 83); PAINT AND COLOUR INDUSTRIES (ICS code(s): 87)

Regulation Type: Regular notification

Draft amendment of the Annexes 2, 3, 4 and 7 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance)

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Distribution date: 28 June 2022 | Final date for Comment: 15 July 2022

Annex 2: The technical regulations for the classification, labelling and packaging of substances and preparations will be updated and thus adapted to technical progress in the EU (18th ATP of the EU CLP Regulation; binding from 23 November 2023).This draft revision updates the list of harmonized classifications:inclusion of 39 substances;amendment of 17 existing entriesone existing entry is split up in twoWith this draft revision, the latest developments in test methods for substances and preparations (OECD) are adopted.  Annex 3: Four substances are included in the candidate list of substance of very high concern. This listing triggers information obligations along the supply chain.Annex 4 (Technical Dossier for Notifications): The requirements are updated in accordance with the specifications for registrations in the EU.Annex 7 (List of new substances for which notification is not required): Three entries are eliminated.

Products Covered: Inorganic chemicals; organic or inorganic compounds of precious metals, of rare- earth metals, of radioactive elements or of isotopes (HS code(s): 28); Organic chemicals (HS code(s): 29); Miscellaneous chemical products (HS code(s): 38); Protection against dangerous goods (ICS code(s): 13.300); CHEMICAL TECHNOLOGY (ICS code(s): 71); RUBBER AND PLASTIC INDUSTRIES (ICS code(s): 83); PAINT AND COLOUR INDUSTRIES (ICS code(s): 87)

Regulation Type: Regular notification

DUS 1659: 2022, Materials in contact with food — Requirements for packaging materials, Second Edition

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Distribution date: 29 June 2022 | Final date for Comment: 28 August 2022

This Draft Uganda Standard provides requirements for food contact surfaces including packaging materials that are intended for that purpose and can be expected to come into contact with food under normal or foreseeable conditions of use." The standard does not include coverings or coatings and substances that are part of the food and may be eaten with it such as sausage skin for which other standards apply. Note: This Draft Uganda Standard was also notified to the TBT Committee.

Products Covered: Plastics and articles thereof (HS code(s): 39); Packaging materials and accessories (ICS code(s): 55.040)

Regulation Type: Revision to Regular Notification

Packaging Food safety Human health Contaminants

DUS 1659: 2022, Materials in contact with food — Requirements for packaging materials, Second Edition

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Distribution date: 29 June 2022 | Final date for Comment: 28 August 2022

This Draft Uganda Standard provides requirements for food contact surfaces including packaging materials that are intended for that purpose and can be expected to come into contact with food under normal or foreseeable conditions of use." The standard does not include coverings or coatings and substances that are part of the food and may be eaten with it such as sausage skin for which other standards apply. Note: This Draft Uganda Standard was also notified to the TBT Committee.

Products Covered: Plastics and articles thereof (HS code(s): 39); Packaging materials and accessories (ICS code(s): 55.040)

Regulation Type: Revision to Regular Notification

Packaging Food safety Human health Contaminants

Draft Amendments to  the Regulations for the Inspection and Examination of Imported Medical Devices 

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Distribution date: 30 June 2022 | Final date for Comment: 04 May 2025

To respond to the new coronavirus pandemic and to ensure the quality of medical devices for protecting the safety and well-being of the public, the Food and Drug Administration proposes to conduct inspection and examination for imported COVID-19 Antigen  Home/Self Tests.

Products Covered: COVID-19 Antigen  Home/Self Test (HS code(s): 3002)

Regulation Type: Regular notification

E09. COVID-19 TBT Human health

Draft Amendments to  the Regulations for the Inspection and Examination of Imported Medical Devices 

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Distribution date: 30 June 2022 | Final date for Comment: 04 May 2025

To respond to the new coronavirus pandemic and to ensure the quality of medical devices for protecting the safety and well-being of the public, the Food and Drug Administration proposes to conduct inspection and examination for imported COVID-19 Antigen  Home/Self Tests.

Products Covered: COVID-19 Antigen  Home/Self Test (HS code(s): 3002)

Regulation Type: Regular notification

E09. COVID-19 TBT Human health

DUS 2536:2022, Standard Test Method for Analysis of Natural Gas by Gas Chromatography , First Edition

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Distribution date: 01 July 2022 | Final date for Comment: 30 August 2022

This Draft Uganda covers the determination of the chemical composition of natural gases and similar gaseous mixtures . This test method may be abbreviated for the analysis of lean natural gases containing negligible amounts of hexanes and higher hydrocarbons, or for the determination of one or more components, as required.

Products Covered: Petroleum gases and other gaseous hydrocarbons. (HS code(s): 2711); Fuels (ICS code(s): 75.160)

Regulation Type: Regular notification

DUS 2536:2022, Standard Test Method for Analysis of Natural Gas by Gas Chromatography , First Edition

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Distribution date: 01 July 2022 | Final date for Comment: 30 August 2022

This Draft Uganda covers the determination of the chemical composition of natural gases and similar gaseous mixtures . This test method may be abbreviated for the analysis of lean natural gases containing negligible amounts of hexanes and higher hydrocarbons, or for the determination of one or more components, as required.

Products Covered: Petroleum gases and other gaseous hydrocarbons. (HS code(s): 2711); Fuels (ICS code(s): 75.160)

Regulation Type: Regular notification

Implementation of Abridged and Verification Review Pathways for New Drug, Initial Registration and Post-Approval Changes Applications of Drug Products, including Vaccines and Biologicals

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Distribution date: 01 July 2022 | Final date for Comment: 04 May 2025

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Human health E09. COVID-19 TBT

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