Regulatory Updates

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: 07 November 2023

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: 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: 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

MAPA/SDA Ordinance No. 724, 23 December 2022 that approves technical regulation on the identity and quality requirements for hamburgers, notified as G/TBT/N/BRA/1275/Add.1 was amended by MAPA/SDA Ordinance No. 916, 20 October 2023.

Products Covered: Prepared or preserved meat or offal of bovine animals (excl. sausages and similar products, finely homogenised preparations put up for retail sale as infant food or for dietetic purposes, in containers of a net weight of

Regulation Type: Addendum to Regular Notification

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

These measures will amend the Cosmetics Regulation 1223/2009 as applicable in GB (“the Cosmetics Regulations”) as they apply in [England, Wales and Scotland]. They will amend permitted levels of certain chemicals in the Cosmetics Regulations.  We will be amending the Cosmetics Regulations to permit the use butylated hydroxytoluene (BHT) up to a maximum concentration of 0.1% in toothpastes, 0.001% in mouthwashes and other leave-on oral care products, and 0.8% in all other cosmetic products. 

Products Covered: Cosmetics products are defined by Article 2(1)(a) of Regulation (EC) No 1223/2009.  ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 26 October 2023 | Final date for Comment: 09 November 2023

Topic 1The chemical treatment specifications to manage regulated insects and mites on imported whole plants and cuttings have been amended in section 2.2.1.6 Pesticide treatments for whole plants and cuttings in the 155.02.06: Importation of Nursery Stock import health standard.The summary of the changes are as follows:  More chemical treatment options to manage insects have been added. Malathion (as a new chemical in Organophosphate chemical group) Cyantraniliprole (this is a new chemical in a new chemical group Diamides) Esfenvalerate and Lambda-cyhalothrin (as two new chemicals in Synthetic pyrethroids chemical group)  2. The chemical treatment options to manage mites have been amended.Single treatment options are reduced from four to two treatment options Combined treatment options increased from four to six treatment options Dicofol, Milbemectin, Bifenazate and Etoxasole removed as chemical treatment options for mites 3. The wording of the methyl bromide treatment requirements for insects and mites have been amended to improve clarity of the existing specifications. Topic 2The Ministry for Primary Industries is suspending the import requirements for plants for planting listed below. These commodities cannot be imported into New Zealand until the import requirements have been reviewed and the suspension has been lifted.Ananas comosus whole plants and cuttings onlyArtocarpus heterophyllus plants in vitroDurio zibethinus whole plants, cuttings and plants in vitroGarcinia mangostana whole plants, cuttings and plants in vitroMangifera indica whole plants and plants in vitroMusa spp. whole plants and plants in vitroNephelium lappaceum whole plants, cuttings and plants in vitroPlinia cauliflora whole plants and plants in vitroPyrus communis cuttingsRibes spp. whole plants Topic 3The Ministry for Primary Industries is implementing emergency measures for Ananas comosus plants in vitro which includes testing and certification pre-export or testing and inspection in Level 2 post-entry quarantine in New Zealand. 

Products Covered: Whole plants, cuttings, and plants in vitro imported as plants for planting

Regulation Type: Regular notification

Distribution date: 26 October 2023 | Final date for Comment: 09 November 2023

The chemical treatment specifications to manage regulated insects and mites on imported Citrus leafless cuttings have been amended in schedule 3: Approved insecticide treatments and Schedule 4: Approved miticide treatments in the MPI import health standard Citrus plants for planting.The summary of the changes are as follows:  More chemical treatment options to manage insects have been added. Malathion (as a new chemical in Organophosphate chemical group) Cyantraniliprole (this is a new chemical in a new chemical group Diamides) Esfenvalerate and Lambda-cyhalothrin (as two new chemicals in Synthetic pyrethroids chemical group)  2. The chemical treatment options to manage mites have been amended.Single treatment options are reduced from four to two treatment options Combined treatment options increased from four to six treatment options Dicofol, Milbemectin, Bifenazate and Etoxasole removed as chemical treatment options for mites3. The wording of the methyl bromide treatment requirements for insects and mites have been amended to improve clarity of the existing specifications.

Products Covered: Leafless cuttings imported as Citrus plants for planting

Regulation Type: Regular notification

Distribution date: 26 October 2023 | Final date for Comment: 09 November 2023

The chemical treatment specifications to manage regulated insects and mites on imported Prunus dormant cuttings have been amended in schedule 3: Approved insecticide treatments and Schedule 4: Approved miticide treatments in the MPI import health standard Prunus plants for planting.The summary of the changes are as follows:  More chemical treatment options to manage insects have been added. Malathion (as a new chemical in Organophosphate chemical group) Cyantraniliprole (this is a new chemical in a new chemical group Diamides) Esfenvalerate and Lambda-cyhalothrin (as two new chemicals in Synthetic pyrethroids chemical group)  2.  The chemical treatment options to manage mites have been amended.Single treatment options are reduced from four to two treatment options Combined treatment options increased from four to six treatment options Dicofol, Milbemectin, Bifenazate and Etoxasole removed as chemical treatment options for mites  3. The wording of the methyl bromide treatment requirements for insects and mites have been amended to improve clarity of the existing specifications.

Products Covered: Prunus plants for planting imported as dormant cuttings

Regulation Type: Regular notification

Distribution date: 26 October 2023 | Final date for Comment: 09 November 2023

The chemical treatment specifications to manage regulated insects and mites on imported Persea americana leafless cuttings have been amended in schedule 3: Approved insecticide treatments and Schedule 4: Approved miticide treatments in the MPI import health standard Persea americana plants for planting.The summary of the changes are as follows:  More chemical treatment options to manage insects have been added. Malathion (as a new chemical in Organophosphate chemical group) Cyantraniliprole (this is a new chemical in a new chemical group Diamides) Esfenvalerate and Lambda-cyhalothrin (as two new chemicals in Synthetic pyrethroids chemical group) 2. The chemical treatment options to manage mites have been amended.Single treatment options are reduced from four to two treatment options Combined treatment options increased from four to six treatment options Dicofol, Milbemectin, Bifenazate and Etoxasole removed as chemical treatment options for mites.3. The wording of the methyl bromide treatment requirements for insects and mites have been amended to improve clarity of the existing specifications.

Products Covered: Leafless cuttings imported as Persea americana plants for planting  

Regulation Type: Regular notification