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

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

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

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

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 amendments to the Rules for conducting clinical and clinical laboratory tests of medical devices

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Distribution date: 23 June 2022 | Final date for Comment: 18 September 2022

The draft amendments to the Rules for conducting clinical and clinical laboratory tests (studies) of medical devices apply to medical products put into circulation on the territory of the Eurasian Economic Union and envisage the following:clarification of the concepts;clarification of the conditions for obtaining clinical data for software that is a medical device;clarification of the conditions of comparability of medical devices when considering clinical data;clarification of the procedure for obtaining a permit for testing;clarification of test requirements;clarification of the grounds for excluding medical organizations from the unified register of authorized organizations authorized to conduct research (testing) of medical devices for the purpose of their registration;definition of requirements for the technical file of the software that is a medical device; clarification of the form of test reports.

Products Covered: Wadding, gauze, bandages and similar products (bandages, adhesive plasters, poultices) impregnated or coated with pharmaceutical substances or packaged in molds or packages for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Devices and devices used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic devices, other electromedical devices and vision testing devices (HS 9018); X-ray, alpha-, beta-, gamma-emitting devices; intended or not intended for medical, surgical, dental or veterinary use, including radiographic or radiotherapy equipment, X-ray tubes and other X-ray generators, high voltage generators, shields and control panels, screens, tables, chairs and similar products for examination and treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs) hairdressing chairs and similar chairs with devices for rotation and simultaneously for tilting and lifting; parts of the above-mentioned products (HS 9402).

Regulation Type: Regular notification

Human health

Draft amendments to the Rules for conducting clinical and clinical laboratory tests of medical devices

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Distribution date: 23 June 2022 | Final date for Comment: 18 September 2022

The draft amendments to the Rules for conducting clinical and clinical laboratory tests (studies) of medical devices apply to medical products put into circulation on the territory of the Eurasian Economic Union and envisage the following:clarification of the concepts;clarification of the conditions for obtaining clinical data for software that is a medical device;clarification of the conditions of comparability of medical devices when considering clinical data;clarification of the procedure for obtaining a permit for testing;clarification of test requirements;clarification of the grounds for excluding medical organizations from the unified register of authorized organizations authorized to conduct research (testing) of medical devices for the purpose of their registration;definition of requirements for the technical file of the software that is a medical device; clarification of the form of test reports.

Products Covered: Wadding, gauze, bandages and similar products (bandages, adhesive plasters, poultices) impregnated or coated with pharmaceutical substances or packaged in molds or packages for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Devices and devices used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic devices, other electromedical devices and vision testing devices (HS 9018); X-ray, alpha-, beta-, gamma-emitting devices; intended or not intended for medical, surgical, dental or veterinary use, including radiographic or radiotherapy equipment, X-ray tubes and other X-ray generators, high voltage generators, shields and control panels, screens, tables, chairs and similar products for examination and treatment (HS 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical devices, dental chairs) hairdressing chairs and similar chairs with devices for rotation and simultaneously for tilting and lifting; parts of the above-mentioned products (HS 9402).

Regulation Type: Regular notification

Human health

DUS 1511:2022, Oxygen for medical use — Specification, Second edition 

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Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022

This Draft Uganda Standard specifies the requirements, methods of sampling and testing of oxygen for medical use only.

Products Covered: - Oxygen (HS code(s): 280440); Medical sciences and health care facilities in general (ICS code(s): 11.020)

Regulation Type: Regular notification

Human health

DUS 1511:2022, Oxygen for medical use — Specification, Second edition 

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Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022

This Draft Uganda Standard specifies the requirements, methods of sampling and testing of oxygen for medical use only.

Products Covered: - Oxygen (HS code(s): 280440); Medical sciences and health care facilities in general (ICS code(s): 11.020)

Regulation Type: Regular notification

Human health

SI 240 - Toilet soap

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Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022

The requirements of the existing Mandatory Standard, SI 240, dealing with toilet soap, shall be declared voluntary. This declaration aims to remove unnecessary obstacles to trade and lower trade barriers.

Products Covered: Toilet soap (HS code(s): 34011); (ICS code(s): 71.100.70)

Regulation Type: Regular notification

SI 240 - Toilet soap

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Distribution date: 22 June 2022 | Final date for Comment: 21 August 2022

The requirements of the existing Mandatory Standard, SI 240, dealing with toilet soap, shall be declared voluntary. This declaration aims to remove unnecessary obstacles to trade and lower trade barriers.

Products Covered: Toilet soap (HS code(s): 34011); (ICS code(s): 71.100.70)

Regulation Type: Regular notification

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