Proyecto de Segunda Revisión del Reglamento Técnico Ecuatoriano PRTE 061 (2R) "Pinturas".

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Distribution date: 04 June 2024 | Final date for Comment: 03 August 2024

El presente reglamento técnico ecuatoriano aplica a los siguientes productos sean estos nacionales o importados que se comercialicen en el Ecuador, definidos de acuerdo a la tabla 1 del PRTE INEN 

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: Regular notification

Proyecto de Primera Revisión del Reglamento Técnico Ecuatoriano PRTE 089 (1R) "Seguridad de los juguetes"

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Distribution date: 04 June 2024 | Final date for Comment: 03 August 2024

El presente reglamento técnico ecuatoriano aplica a los siguientes productos sean estos nacionales o importados que se comercialicen en el Ecuador: Juguetes destinados a ser utilizados por niños de edad inferior a los 14 años

Products Covered: Triciclos, patinetes, coches de pedal y juguetes similares con ruedas; coches y sillas de ruedas para muñecas o muñecos; muñecas o muñecos; los demás juguetes; modelos reducidos y modelos similares, para entretenimiento, incluso animados; rompecabezas de cualquier clase (Código(s) del SA: 9503)

Regulation Type: Regular notification

Proyecto de la Cuarta Revisión del Reglamento Técnico Ecuatoriano PRTE 006 (4R) "Extintores portátiles y agentes de extinción de fuego"

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Distribution date: 03 June 2024 | Final date for Comment: 02 August 2024

Este reglamento técnico ecuatoriano aplica a los siguientes productos sean éstos nacionales o importados que se comercialicen en el Ecuador:Extintores portátiles que tienen una capacidad de hasta 27 kg (60 lb.), independientemente del agente de extinción que utilicen, la capacidad del mismo o de la clase de fuego a que se destine;Extintores sobre ruedas que tienen una capacidad de hasta 125 L (33 galones) para unidades de espuma y de 13,6 kg a 158,8 kg (30 lb a 50 lb) para otros tipos de extintores, independientemente del agente de extinción que utilicen, de la cantidad del mismo o de la clase de fuego al que se destine;Cilindro, carcasa o cuerpo del extintor portátil o extintor portátil sobre ruedas.Medios de extinción o agentes de extinción de fuego de Polvo Químico Seco, CO2 y agentes de extinción de fuego a base de agua, agentes limpios.

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: Regular notification

Establece condiciones y requisitos para autorizar el ingreso o formulación y uso de muestras de plaguicida solo para experimentación, y deroga Resolución N° 92 de 2002

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Distribution date: 31 May 2024 | Final date for Comment: 24 July 2024

La medida notificada, responde a la necesidad de realizar la actualización de los requerimientos exigibles por el SAG, para la autorización del ingreso y/o formulación de muestras experimentales.Por otro lado, se requiere:Estipular la descripción de los pasos y plazos asociados a la evaluación y resolución del trámite administrativo, para el cumplimiento de los principios celeridad, economía procedimental y de no formalización establecidos por la Ley Nº 19.880.Establecer lineamientos para la fabricación o el ingreso de muestras de plaguicidas destinadas a experimentación. Mayores detalles pueden ser revisados en el documento adjunto a esta notificación.

Products Covered: Muestras experimentales de plaguicidas para uso agrícola.

Regulation Type: Regular notification

Updates to medicine labelling rules: Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety 

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Distribution date: 31 May 2024 | Final date for Comment: 30 July 2024

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods.  These standards, known as Therapeutic Goods Orders (TGOs), can specify particular labelling, packaging or other requirements.  Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. To support the safe use of medicines, the TGA is proposing to update labelling requirements in the following TGOs:Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92). The TGA is conducting a public consultation between 30 May and 11 July 2024 to seek feedback on proposed changes to TGO 91 and TGO 92 to address 3 medicines safety related matters.

Products Covered: Medicines

Regulation Type: Regular notification

Labelling

Proposed changes to the Industrial Chemicals (General) Rules and Categorisation Guidelines

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Distribution date: 31 May 2024

An outline of the changes made to the proposed amendment following the consultation period can be found here:Response to feedback on proposed changes to AICIS categorisation, reporting & record keeping requirements | Australian Industrial Chemicals Introduction Scheme (AICIS)

Products Covered: All industrial chemicals used in Australia.

Regulation Type: Addendum to Regular Notification

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-ARe-7/5900-3 as of 28 May 2024

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Distribution date: 30 May 2024

This letter introduces a temporary restriction on import of live poultry, poultry products, eggs, equipment for poultry, feed and feed additives for birds from Australia to the territory of the Russian Federation and on transit of live poultry through the Russian territory due to the outbreak of highly pathogenic avian influenza in Australia.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, incubation egg of poultry, Incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds (HS code(s): 0105; 0207; 0208; 0209; 0210; 0407; 0408; 0410; 0504; 0505; 0511; 1506; 1510; 1516; 1518; 1601; 1602; 1603; 190220; 190420; 2102; 2104; 2106; 2309; 2936; 3504; 3507; 3808; 3824; 3923; 3926; 4206; 4415; 4416; 4421; 7020; 7309; 7310; 7326; 7616; 843610; 84362; 843680; 860691; 8609; 8716; 950810; 9705)

Regulation Type: Emergency notifications (SPS)

Animal health Animal diseases Zoonoses Avian Influenza

The Egyptian Standard ES 8827 for "Fertilizers and soil conditioners- chitosan"

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Distribution date: 29 May 2024

Products covered: Fertilizers (ICS code(s): 65.080)This addendum concerns the notification of the Ministerial Decree No.141/2024 (2 pages, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 8827 for "Fertilizers and soil conditioners- chitosan"; (14 page(s), in Arabic)It should be noted that the draft of this standard was formerly notified in G/TBT/N/EGY/403 dated 9 February 2024.Worth mentioning is that this standard has been formulated according to National Studies.Producers and importers are kept informed of any amendments in the Egyptian standards through the publication of administrative orders in the official gazette.Date of adoption: 22 April 2024Date of entry into force:  22 May 2024Agency or authority designated to handle comments and text available from:National Enquiry Point Egyptian Organization for Standardization and Quality 16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: [email protected]/[email protected]: http://www.eos.org.egTel: + (202) 22845528 Fax: + (202) 22845504

Products Covered: Fertilizers (ICS code(s): 65.080)

Regulation Type: Addendum to Regular Notification

Lonza Greenwood LLC; Filing of Color Additive Petition; Notification of Petition

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Distribution date: 27 May 2024

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Lonza Greenwood LLC, proposing that the color additive regulations be amended to provide for the safe use of sodium copper chlorophyllin in dietary supplement capsules in an amount ranging from 0.08 to 0.4 percent of the weight of the capsule, and to add fescue grass (Festuca arundinacea) as a permitted source of the color additive. The color additive petition was filed on 26 March 2024.

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); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Human health Food safety

Modification of Annexes 2 and 3 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance; ChemO); 

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Distribution date: 27 May 2024 | Final date for Comment: 26 July 2024

Annex 2 ChemO :1. Harmonized classifications and labeling of substances (21st ATP of the EU-CLP regulation): 28 substances or groups of substances are listed in the List of harmonized classifications and labeling of dangerous substances, and 24 existing entries are modified.2. The new EU hazard classes according to delegated reulation (EU) 2023/707 for endocrine disruptors and chemicals which are difficult to degrade (persistent), which accumulate in organisms (bioaccumulation) or which, due to their mobility, can reach surface water, groundwater and ultimately drinking water, become applicable in Switzerland. They will then become mandatory in stages, first for substances, then for preparations.3. The latest developments in test methods (OECD, UN Manual of Tests and Criteria) are incorporated into Swiss legislation.Seven new entries are added to Appendix 3 ChemO (list of candidate substances). In addition, one entry is updated.

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); Environment. Health protection. Safety (ICS code(s): 13); 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

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