Updates on Regulatory Actions in Colombia, Costa Rica, El Salvador, Honduras, Mexico
INVIMA in Colombia has updated the guide for import and export intentions for food and medicines. The country has also issued regulations on adverse event reporting excluding dietary supplements. In Costa Rica, the executive considers a front labeling bill unconstitutional due to regional agreements. Stay informed about the latest regulatory updates in the region.
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Presentation Transcript
Regulatory Committe April 2024
AGENDA REGULATORY UPDATE - - - - - Colombia Costa Rica El Salvador Honduras M xico ALANUR ACTIVITIES -ALANUR committes
COL. INVIMA updates the guide for filling out import and export intentions for food and medicines. Action required : Regulatory impact : To implement/ Follow up/ None Product/Company/Authority Executive summary: INVIMA updated the guide for filling out import and export intentions for food products, medicines and supplements. The document contains the general considerations that must contain the requests for registration or import license and payments of these goods through the platform of the single window of foreign trade (VUCE). The guide is already in force. The guide indicates the application procedures to be carried out to obtain the import and export approval for finished products or raw materials for food, medicines, phytotherapeutic products, supplements, homeopathic products, among others. Country comments: INVIMA may apply Codex Alimentarius standards in the absence of a specific national standard for an imported product.
COL. Publication of Adverse Event Reporting Regulations without application to Dietary Supplements Action required : Regulatory impact : To implement/ Follow up/ None Product/Company/Authority Executive summary: Publication of Resolution 2024/015321 on the content and periodicity of adverse effect reports and the installation of pharmacovigilance systems, highlighting that in Article 1, paragraph 1, food supplements are expressly excluded from compliance with this resolution. Country comments: None
CR. Executive considers front labeling bill unconstitutional Action required : Regulatory impact : To implement/ Follow up/ None Product/Company/Authority Executive summary: The Special Permanent Commission on Disability and Senior Citizens met to discuss the initiative that seeks to approve a law on front labeling with nutritional warnings for food products and beverages with non-alcoholic content. The country's legislation obeys the General Treaty of Central American Economic Integration, due to the constitutional hierarchy of international treaties, which is why it considers that the labeling issue should be discussed within the framework of the Council of Ministers of Economic Integration. Country comments: It was pointed out that the approval of the dossier in question would be unconstitutional, since it would constitute a violation of regional agreements in force, such as the Central American Regulation on nutritional labeling.
CR. Supreme Court orders elimination of provision requiring front labeling of imported food products to be concealed Action required : Regulatory impact : To implement/ Follow up/ None Product/Company/Authority Executive summary: The Constitutional Chamber of the Supreme Court of Justice of Costa Rica announced the decision to annul the circular of the Ministry of Health that established the obligation to hide nutrition warning labels on imported foods. This circular, in force since June 2023, applied to those applying for food registrations and required importers and distributors, as a condition to obtain these registrations, to hide the excess warning labels on the original labels of the products. Country comments: the judges consider that the Ministry's determination to conceal the labeling goes against the right to health and the right of consumers to receive clear and understandable information when purchasing foods that could significantly influence their well-being.
HON. Executive publishes resolution to adopt new Central American regulations for sanitary registration of processed foodstuffs Product/Company/Authority impact : Action required : Regulatory To implement/ Follow up/ None Executive summary: Ministerial Agreement No. 040-2024, which adopts the new Central American Technical Regulation (RTCA) for Processed Foods, which includes the procedure for the granting, renewal and modification of the sanitary registration of these products.The new regulation excludes processed foods ready for human consumption that are packaged at the time they are ordered, requested or purchased by the consumer. Also, certain data and documents were changed for the requirements to apply for the sanitary registration, as well as for its modification or renewal. Country comments: The validity of the registration was maintained at 5 years.
ELS. Executive enacts extension to August of the effective date of the Law that creates the Superintendence of Sanitary Regulation. Action required : Regulatory impact : To implement/ Follow up/ None Product/Company/Authority Executive summary: The Executive Power enacts the extension of the entry into force of the Law that creates the Superintendence of Health Regulation until August 9, 2024. It is worth remembering that this entity will be in charge of regulating products such as medicines, assuming and centralizing the functions of some public agencies, such as the National Directorate of Medicines (DNM), which will be eliminated. food and beverages, Country comments: the Law provided that its provisions would be effective as of April 1.
MX. Supreme prepackaged foods constitutional Product/Company/Authority impact : Court declares provisions Action required : on labeling of Regulatory To implement/ Follow up/ None Executive summary: The Supreme Court of Justice declared the constitutionality of regulatory provisions regarding the labeling of prepackaged food and non-alcoholic beverages, particularly those contained in the General Health Law and in the Modification to the Mexican Official Standard NOM-051-SCFI/SSA1- 2010 on general specifications on the matter. Thus, with respect to the General Health Law, the provisions referring to labeling, included in articles 212 and 215, indicate that they are valid since they provide information on the content of products associated with risk factors for the development of diseases such as diabetes and hypertension; protect the rights of consumers and nutritious food; allow consumers to make healthier choices to quickly identify products that are harmful to their health. Country comments: The Judiciary indicates that it does not violate the freedom of commerce, since it does not prevent companies from engaging in their activity and does not restrict their participation in the market if they comply with the provisions.
ALANUR ACTIVITIES
TEMAS REGULATORIOS GUA. - Redacci n de art culo que saldr publicado en redes sociales sobre la no aplicaci n del etiquetado frontal nutrimental en suplementos y alimentos para reg menes especiales. Env o de cartas de postura a la GREMAB y a C mara Legislativa, Ministerio de Econom a y Ministerio de Salud. GREMAB solicit apoyo para realizar capacitaci n con autoridades sobre niveles recomendados de fibra, extractos bot nicos y declaraciones de propiedades nutricionales y saludables (fecha a n por confirmar), de preferencia ser a participaci n presencial de ALANUR y sus expertos - - UY - - Revisando comentarios de postura oficial ALANUR Pr xima reuni n martes 30 de abril a las 11 hrs CDMX/12 hrs CO/14 hrs BR. PROGRAMA DE TRABAJO AR - CAVEDI, elaboraci n de postura conjunta sobre proyecto para prohibir la venta directa de suplementos alimenticios 20XX Presentaci n de lanzamiento 11
CAPACITACIN ALANUR PROGRAMA DE TRABAJO 20XX Presentaci n de lanzamiento 12
EUROMONITOR Lic. Carmen Silva Acercamiento para realizar trabajos conjuntos. Tambi n contactaron a ILAR Ofrecen: - - - Data sobre el mercado global de suplementos alimenticios Fecha tentativa: 2 de mayo a las 9 hrs. Gestiones: zoom de ALANUR SOLICITAN : compartir datos de correo electr nico de los participantes PROGRAMA DE TRABAJO 20XX Presentaci n de lanzamiento 13
ESTUDIO CUALITATIVO PARA DETERMINAR CARACTER STICAS Y VALOR DEL MERCADO EN CAM Mayo / Julio 2024 1. - - - Entrevistas con asociados ALANUR Acuerdo de confidencialidad ALANUR/EMPRESAS Apoyo para entrevistar al rea de marketing y regulatorio de las empresas Env o de un correo con datos solicitando espacio en las agendas para realizar entrevistas (tiempo 1 hora aproximadamente) 2. Entrevistas con no asociados ALANUR (Asociaciones de Venta Directa en CAM) 3. Entrevistas a consumidores - Apoyo de FECAICA 3. Entrevistas a profesionales de la salud 4. Mistery shopper y b squeda de data de consumo en CAM AVANCES Abril 2024 Objetivo general y particulares Cronograma de trabajo Formatos de entrevista Dise o de entrevista PROGRAMA DE TRABAJO 20XX Presentaci n de lanzamiento 14
ASAMBLEA ALANUR (10 y 11 de junio 2024) 20XX Presentaci n de lanzamiento 15
ALANUR ALANUR cuenta con una tarifa especial de $189 + imp en habitaci n est ndar sencilla con desayuno incluido ($20 + imp segunda persona). S lo ser necesario enviar un e-mail a reservas@hiltonlasabana.com o Johanna.r odriguez@hilton.com y comunicar que ser n participantes de la Asamblea General de Asociados de ALANUR durante las fechas entre el 10 al 12 de junio del 2024.
THANKS! Alianza Latinoamericana de Nutrici n Responsable
