Distribution date: 27 October 2023 | Final date for Comment: 26 November 2023

The Minimum Requirements for Biological Products will be amended as follows: The standard for “Frozen Human Red Blood Cells” that is to be newly approved will be added. And regarding the standard for “Recombinant Respiratory Syncytial virus Vaccine”, the section of “Cell Bank” and “Identification test on cultured CHO cell” will be partially amended. In addition, regarding the standard for “Coronavirus (SARS-CoV-2) RNA Vaccine”, the section such as “Descriptive definition” , “Bulk material” and “Identity test” will be partially amended. The Public Notice on National Release Testing will be amended as follows: The quantity for “Coronavirus (SARS-CoV-2) RNA Vaccine” will be partially amended. And, the criterion, fee and quantity for “Freeze-dried Gas Gangrene Antitoxin, Equine”, “Freeze-dried Diphtheria Antitoxin, Equine”, “Freeze-dried Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)”, “Freeze-dried Habu Antivenom, Equine”, “Freeze-dried Botulism Antitoxin, Equine” and “Freeze-dried Mamushi Antivenom, Equine” will be partially amended. In addition, “Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine (bulk material)” and “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Combined Vaccine (bulk material)” will be deleted.

Products Covered:  Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 27 October 2023 | Final date for Comment: 26 December 2023

L'article 205 de la loi n° 2022-1726 du 30 décembre 2022 de finances pour 2023 acte du transfert de compétences sur les produits cosmétiques et de tatouage de l’Agence nationale de sécurité des produits de santé (ANSM) à l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES) et à l'autorité administrative chargée de la concurrence et de la consommation mentionnée à l'article L.522-1 du code de la consommation (DGCCRF).Le III. de ce même article prévoit que dans les conditions prévues à l'article 38 de la Constitution, le Gouvernement est autorisé à prendre par voie d'ordonnance, dans un délai d'un an à compter de la promulgation de la présente loi, les mesures relevant du domaine de la loi visant notamment à prévoir un dispositif de certification des établissements mentionnés à l'article L. 5131-2 du code de la santé publique attestant du respect des bonnes pratiques de fabrication des produits cosmétiques mentionnés à l'article L. 5131-1 du même code afin d'assurer un niveau élevé de protection de la santé humaine.Le projet d'ordonnance entend ainsi mettre en place, au niveau national, un processus de certification des bonnes pratiques de fabrication des produits cosmétiques de certaines catégories d'établissements.Les modalités de mise en oeuvre du système de certification sont en cours d'élaboration. Conformément à l'article premier du projet d'ordonnance, elles seront précisées par un décret en Conseil d'Etat qui sera également notifié à la Commission européenne.

Products Covered: Produits cosmétiques

Regulation Type: Regular notification

Distribution date: 07 November 2023 | Final date for Comment: 28 April 2025

La presente modificación, tiene por objeto establecer el esquema del Reliance para optimizar el proceso de ingreso de nuevas opciones terapéuticas seguras, eficaces y de calidad, para la atención de enfermedades que requieren terapias avanzadas (principalmente medicamentos de origen biotecnológico) como el cáncer, diabetes mellitus, entre otras.

Products Covered: Medicamentos (HS: 30.04)

Regulation Type: Regular notification

Distribution date: 08 November 2023 | Final date for Comment: 07 January 2024

La Dirección General de Sanidad Vegetal (DGSV) es la encargada de la protección fitosanitaria en México, para lo cual, establece las medidas fitosanitarias que mitiguen el riesgo de introducción o diseminación de plagas reglamentadas de los vegetales, sus productos y subproductos. FundamentaciónArtículos 2, 3, 6, 7 fracciones XIII, XVIII, XIX, XXII, 8, 19 fracciones I inciso e) y IV de la Ley Federal de Sanidad Vegetal;Artículos 1, 54, 55 y 56 del Reglamento de la Ley Federal de Sanidad Vegetal; 1, 14 fracción III, 15 fracciones I, X, XV, y XIX del Reglamento Interior del Senasica;Artículos 1, 2, 3, 4 y 7 del Acuerdo por el que se establece el módulo de requisitos fitosanitarios para la importación de mercancías reguladas por la Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SADER) en materia de sanidad vegetal;Artículos 1, 5, 6 y 16 del Acuerdo por el que se dan a conocer los criterios generales aplicados por México para el establecimiento y modificación de requisitos en materia de saniedad e inocuidad animal, vegetal, acuicola y pesquera para la importación de mercancías reguladas por la SADER, a través del Senasica se establecen las medidas fitosanitarias que deben cumplirse para la importación de vegetales, sus productos y subproductos. MotivaciónDerivado de la reclasificación de la condicicón fitosanitaria de la palomilla marrón de la manzana (Epiphyas postvittana), como plaga no cuarentenaria para Estados Unidos de América (EUA) declarada por Organización Nacional de Protección Fitosanitaria (ONPF) de dicho país, la DGSV llevó a cabo una negociación de las medidas fitosanitarias aplicables; como resultado de dicha gestión, ambas ONPF acordaron modificar los requisitos fitosanitarios establecidos para la importación a México, de productos hospederos provenientes de EUA, los cuales se enlistan en el Anexo 1. Se determina:Modificar el apartado de regulación para E. postvittana de los requisitos fitosanitarios para la importación a México de los productos hospederos de dicha plaga, originarios y procedentes de EUA señalados en el Anexo 1, para quedar como sigue:El Certificado Fitosanitario emitido por la autoridad fitosanitaria de Estados Unidos de América, debe señalar en el apartado de declaratoria adicional lo siguiente:"El producto fue inspeccionado y encontrado libre de cualquier estado biológico de Epiphyas postvittana".

Products Covered: Diversos productos hospederos de Epiphyas postvittana, mismos que se enlistan en el documento anexo.

Regulation Type: Regular notification

Distribution date: 08 November 2023 | Final date for Comment: 07 January 2024

The document is to strengthen the supervision of inspecting for cosmetics, and safeguard the consumers’ health.

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

Regulation Type: Regular notification

Distribution date: 09 November 2023 | Final date for Comment: 28 April 2025

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH), an outbreak of highly pathogenic avian influenza virus (HPAI) was registered in Norway. In this regard, since 20 October 2023, temporary restrictions have been introduced on the importation to the territory of Kazakhstan from Norway of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (except for feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermic treatment (feathered game), the former used equipment for keeping, slaughtering and butchering birds susceptible to highly pathogenic avian influenza virus (HPAI), as well as transit through the territory of Kazakhstan of live birds. 

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and butchering birds

Regulation Type: Emergency notifications (SPS)

Distribution date: 17 November 2023 | Final date for Comment: 16 January 2024

La finalidad de esta norma técnica es establecer los requisitos y la documentación a presentar para solicitar el registro sanitario y además, entregar elementos para la vigilancia de hemoderivados de uso humano para asegurar la calidad, seguridad y eficacia de estos productos, reforzar la importancia de las buenas prácticas de manufactura, así como incorporar definiciones completas y actualizadas que sirvan de guía para reguladores y regulados de manera de otorgar transparencia y mayor conocimiento.

Products Covered: Productos Farmacéuticos

Regulation Type: Regular notification

Distribution date: 21 November 2023 | Final date for Comment: 20 January 2024

The draft regulation states that all of the Clothing produced within the country or imported, distributed, and marketed in the country shall fulfil the Technical Specification requirements. The producers who produce these products therefore shall comply with those requirements proven by having a Product Certificate for Using Conformity Mark.The product certificate on conformity marking shall be issued by a Product Certification Body which has been accredited by KAN and appointed by the Minister of Industry through testing of the conformity of the products' quality against Technical Specification requirements.Directorate of the Textile, Leather and Footwear Industry, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a technical guidance of the decree, which covers the procedure of Product Certification and Conformity Marking.Products that are distributed in the domestic market that originated domestically and are imported shall meet requirements listed in Annex II of the Technical Specification of Apparel.

Products Covered: HS code(s): 6101; 6102; 6103; 6104; 6106; 6107; 6108; 6109; 6110; 6112; 6113; 6114; 6202; 6203; 6204; 6205; 6206; 6207; 6208; 6210; 6211. As indicated in the Annex I

Regulation Type: Regular notification

Distribution date: 21 November 2023 | Final date for Comment: 28 April 2025

Burundi, Kenya, Rwanda, Tanzania and Uganda would like  to inform the WTO Members that the Draft East Africa Standard; DEAS 801:2022, Soya protein products - Specification, Second Edition, notified in  G/SPS/N/BDI/33, G/SPS/N/KEN/189, G/SPS/N/RWA/26, G/SPS/N/TZA/227, and G/SPS/N/UGA/229 was adopted by the East African Community Council of Ministers on 25 August 2023  as East Africa Standard, EAS 801:2022, Soya protein products - Specification, Second Edition. This specification can be purchased by contacting the TBT NEP through [email protected] 

Products Covered: Peptones and their derivatives; other protein substances and their derivatives, n.e.s.; hide powder, whether or not chromed (excl. organic or inorganic compounds of mercury whether or not chemically defined) (HS code(s): 3504); Cereals, pulses and derived products (ICS code(s): 67.060)

Regulation Type: Addendum to Regular Notification

Distribution date: 21 November 2023 | Final date for Comment: 28 April 2025

Burundi, Kenya, Rwanda, Tanzania and Uganda would like  to inform the WTO Members that the Draft East Africa Standard; DEAS 801:2022, Soya protein products - Specification, Second Edition, notified in  G/SPS/N/BDI/33, G/SPS/N/KEN/189, G/SPS/N/RWA/26, G/SPS/N/TZA/227, and G/SPS/N/UGA/229 was adopted by the East African Community Council of Ministers on 25 August 2023  as East Africa Standard, EAS 801:2022, Soya protein products - Specification, Second Edition. This specification can be purchased by contacting the TBT NEP through [email protected] 

Products Covered: Peptones and their derivatives; other protein substances and their derivatives, n.e.s.; hide powder, whether or not chromed (excl. organic or inorganic compounds of mercury whether or not chemically defined) (HS code(s): 3504); Cereals, pulses and derived products (ICS code(s): 67.060)

Regulation Type: Addendum to Regular Notification