Distribution date: 10 October 2024 | Final date for Comment: 20 April 2025

Fourth revision (4R) of Ecuadorian Technical Regulation (RTE) No. 006 "Portable fire extinguishers and fire extinguishing agents" 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained. G/TBT/N/ECU/528/Add.1 - 2 - The Republic of Ecuador hereby advises that the fourth revision (4R) of Ecuadorian Technical Regulation (RTE) No. 006 "Portable fire extinguishers and fire extinguishing agents" will enter into force on 4 April 2025. It should be noted that, with respect to this Regulation, Ecuador has followed all the transparency and notification guidelines determined by the WTO. Thus, on 3 June 2024, in document G/TBT/N/ECU/528, the draft fourth revision (4R) of Ecuadorian Technical Regulation (PRTE) No. 006 "Portable fire extinguishers and fire extinguishing agents" was notified for 60 days on the WTO ePing platform for comments. Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries) Subsecretaría de la Calidad (Under-Secretariat for Quality) TBT enquiry point: Primary enquiry point: Patricio Fernando Alvarez Chávez Secondary enquiry point: Cristian Eduardo Yépez Jaramillo Plataforma Gubernamental de Gestión Financiera; Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Piso 8 Bloque amarillo Quito EC170522 Tel.: (+593 2) 394 8760; Ext. 2254; Ext. 2252 Email: [email protected]; [email protected]; [email protected]; [email protected] Website: http://www.produccion.gob.ec __________

Products Covered: PRODUCTOS DIVERSOS DE LAS INDUSTRIAS QUÍMICAS (Código(s) del SA: 38); REACTORES NUCLEARES, CALDERAS, MÁQUINAS, APARATOS Y ARTEFACTOS MECÁNICOS; PARTES DE ESTAS MÁQUINAS O APARATOS (Código(s) del SA: 84)

Regulation Type: Addendum to Regular Notification

Distribution date: 10 October 2024 | Final date for Comment: 08 December 2024

Draft technical regulations for vanilla to be marketed on the domestic market and/or for export (12 pages, in French). This draft Order concerns all forms of vanilla (pods, seeds and powder) belonging to the species Vanilla fragrans (Salisbury) Ames syn. Vanilla planifolia Andrews. It establishes the physico-chemical requirements to be met by each of these forms of vanilla, including water content, vanillin content and pod length. It also provides guidance on packaging, packing, storage, sampling and controls. The list of applicable definitions and the test methods are contained in the annexes. G/TBT/N/MDG/1 - 2 -

Products Covered: Coffee, tea, maté and spices (HS code: 09); Vanilla (HS code: 09051000): General considerations. Terminology. Standardization. Documentation (ICS code: 01); Agriculture (ICS code: 65)

Regulation Type: Regular notification

Distribution date: 10 October 2024 | Final date for Comment: 20 April 2025

Ecuadorian Technical Regulation RTE No. 061 (2R): "Paints" The Republic of Ecuador hereby advises that Ecuadorian Technical Regulation (RTE) No. 061 (2R): "Paints" will enter into force on 4 April 2025. 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained. G/TBT/N/ECU/529/Add.1 - 2 - It should be noted that, with respect to this Regulation, Ecuador has followed all the transparency and notification guidelines determined by the WTO. Thus, on 4 June 2024, in document G/TBT/N/ECU/529, the draft second revision (2R) of Ecuadorian Technical Regulation (RTE) No. 061: "Paints" was notified for 60 days on the WTO ePing platform for comments. No comments were received during this period. Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries) Subsecretaría de la Calidad (Under-Secretariat for Quality) TBT enquiry point: Primary enquiry point: Patricio Fernando Alvarez Chávez Secondary enquiry point: Cristian Eduardo Yépez Jaramillo Plataforma Gubernamental de Gestión Financiera; Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Piso 8 Bloque amarillo Quito EC170522 Tel.: (+593 2) 394 8760; Ext. 2254; Ext. 2252 Email: [email protected]; [email protected]; [email protected]; [email protected] Website: http://www.produccion.gob.ec __________

Products Covered: Pinturas y barnices a base de polímeros sintéticos o naturales modificados, dispersos o disueltos en un medio no acuoso; disoluciones en disolventes orgánicos volátiles de productos citados en las partidas 3901 a 3913, con una proporción de disolvente > 50% del peso de la disolución (exc. disoluciones a base de poliésteres o de polímeros acrílicos o vinílicos, así como disoluciones en colodiones) (Código(s) del SA: 320890); Pinturas y barnices a base de polímeros sintéticos o naturales modificados, dispersos o disueltos en un medio acuoso (Código(s) del SA: 3209); Las demás pinturas y barnices; pigmentos al agua preparados de los tipos utilizados para el acabado del cuero (Código(s) del SA: 3210); Pigmentos, incl. el polvo y laminillas metálicos, dispersos en medios no acuosos, líquidos o en pasta, de los tipos utilizados para la fabricación de pinturas; hojas para el marcado a fuego de los tipos utilizados para encuadernaciones o guarniciones interiores de sombreros; tintes y demás materias colorantes, n.c.o.p., presentados en formas o envases para la venta al por menor (Código(s) del SA: 3212); Colores para pintura artística, la enseñanza, la pintura de carteles, para matizar o para entretenimiento y colores simil., en pastillas, tubos, botes, frascos, o en formas o envases simil. (Código(s) del SA: 3213)

Regulation Type: Addendum to Regular Notification

Distribution date: 10 October 2024 | Final date for Comment: 09 December 2024

The notified document addresses the need to update the SAG requirements contained in the regulatory provisions of Resolution No. 9.074/2018 in accordance with Resolution No. 1.557/2014. In addition, it incorporates new terms introduced in the new regulations and includes, inter alia, digitalization and electronic signatures. Further details can be found in the document attached to this notification.

Products Covered: Special authorizations for natural and synthetic pesticides.

Regulation Type: Regular notification

Distribution date: 15 October 2024 | Final date for Comment: 20 April 2025

Resolution 742, 10 August 2022 - previously notified through G/TBT/N/BRA/955/Add.1 - which establishes the minimal technical requirements for relative bioavailability and bioequivalence studies that supports dossier of consent for clinical research, marketauthorization or post-market authorization of medicines, in the terms of this resolution, was change by Resolution 931, 09 October 2024. The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/5740831/RDC_931_2024_.pdf/42c43a0e-99cd-4114-9fe1-d5b6421a68d1 

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

Regulation Type: Addendum to Regular Notification

Distribution date: 16 October 2024 | Final date for Comment: 15 November 2024

The Minimum Requirements for Radiopharmaceuticals are to be partially amended to add the standards for a radiopharmaceutical to be newly approved.

Products Covered: Pharmaceutical Products (HS: 30)

Regulation Type: Regular notification

Distribution date: 17 October 2024 | Final date for Comment: 20 April 2025

Products Covered: E-cigarettes

Regulation Type: Addendum to Regular Notification

Distribution date: 17 October 2024 | Final date for Comment: 16 December 2024

This document specifies the general principles, requirements, testing methods, and judgment rules for restricting excessive packaging in express.This document applies to non-circular express packages entering the express delivery channel.

Products Covered: express packaging items, include courier boxes（cartons, boxes and cases, of corrugated paper or paperboard）, courier bags（sacks and bags of polymers of ethylene, for the conveyance or packing of goods）, express plastic bags and packaging tapes (HS code(s): 300510; 39232; 481910); (ICS code(s): 03.240)

Regulation Type: Regular notification

Distribution date: 17 October 2024 | Final date for Comment: 16 December 2024

This document specifies the terms and definitions, product classification, general requirements, performance requirements, test methods, inspection rules and marking, packaging, transportation and storage of fireproof coatings for concrete structure.This document applies to fireproof coatings on the  concrete surface of highways, railroads, urban transportation tunnels and fire embankment in petrochemical storage tank area and other industrial and civil buildings (structures).

Products Covered: Fireproof coatings for concrete structure (HS code(s): 3816); (ICS code(s): 13.220.50)

Regulation Type: Regular notification

Distribution date: 17 October 2024 | Final date for Comment: 16 December 2024

The document is to strengthen safety risks monitoring for cosmetics, promote the development of cosmetics industry and safeguard the consumers’ health.

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

Regulation Type: Regular notification