The National Health Surveillance Agency (ANVISA in Portuguese) has published an amendment to the Normative Instruction – IN nº 211, of March 1, 2023, which establishes the technological functions, maximum limits and conditions of use of food additives and technological aids authorized for use in food.
Day: 17/07/2024
Brazil – ANVISA publishes amendments to the lists of constituents, limits of use, declarations and complementary labeling of food supplements
The National Health Surveillance Agency (ANVISA in Portuguese) has published amendment the Regulatory Instruction – IN No. 28, of July 26, 2018, which establishes the lists of constituents, limits of use, declarations and complementary labeling of food supplements.
Colombia – Regional eco labeling promotes sustainability in Latin America and the Caribbean
The first regional eco-labeling program was launched in Latin America and the Caribbean, led by regulators, standardizers and accreditation bodies. The aim is to standardize the use of eco-labeling throughout the region by providing consumers with transparent and reliable information on the environmental impact of purchased products.
The regional eco-labeling program, a joint initiative of Costa Rica, Ecuador and Mexico, seeks to unify criteria to define the categories under which it will operate. This will make it possible to identify environmentally responsible products, thus strengthening a more conscious and sustainable regional market.
Brazil – ANVISA published the 4th edition of the questions and answers document related to nutrition labeling
The National Health Surveillance Agency (ANVISA in Portuguese) has published the 4th edition of the questions and answers document related to nutrition labeling.
In this edition, changes were made to questions 44, 45 and 173 on the nutritional labeling of sweeteners, due to changes in the definition and framing of these products, made by Resolution of the Collegiate Council (RDC) 818/2023.
Questions 17 and 19 were modified to adapt the information related to DRC 839/2023, which seeks to demonstrate the safety of the use of novel foods and novel ingredients, and which repealed RES 16/1999.
Questions 46 and 47 were included in the document to clarify the additional nutrients to be declared mandatory in the nutritional table of special purpose foods.
Questions 55 and 60 have been revised to provide greater clarity and precision with respect to added sugars present in ingredients used as a source of dietary fiber, in accordance with the diversity of nomenclature, composition and methods used in the production of these ingredients.
Questions 160 and 161 were also added to clarify some readability requirements for the simplified declaration and the linear declaration of the nutrition table, and question 198, which addresses the application of tolerance values to the %DV declaration.
Colombia – Statement from the Ministry of Health on the project to update dietary supplements
On June 6, the national public consultation of the draft decree “Whereby the sanitary conditions and requirements regarding dietary supplements are established, and other provisions are issued” began. This draft decree corresponds to the comprehensive update of the legislation regarding dietary supplements in Colombia, which seeks to repeal Decree 3249 of 2006 and its amending or complementary rules, such as Decree 3863 of 2008, Decree 272 of 2009 and Resolution 3096 of 2007.
The project is published in the Ministry’s web page and the consultation is open until July 17 at 6:00 p.m.
Some of the aspects to be updated are related to:
- Reference values and maximum tolerable intake levels.
- Specific Good Supply Practices.
- Harmonization of regulatory requirements with the agreements made within the framework of the Pacific Alliance with Chile and Peru.
- Adjustment of the sanitary registration issuance process, making some requirements more flexible, such as the Certificate of Good Manufacturing Practices.
- Definition of a new subcategory of products, dietary supplements for athletes.
- Establishment of minimum conditions for the use of non-psychoactive cannabis in the manufacture of dietary supplements.
All those who are interested in participating in the national public consultation can refer to the following link: https://www.minsalud.gov.co/normatividad_nuevo/forms/allitems.aspx
Comments on the draft decree must be accompanied by the appropriate technical justification during the national public consultation process.
It should be noted that, since this is a technical regulation, this process is just beginning. Once the national public consultation is completed, the comments received will be answered, adjustments will be made to the draft decree, and the required process will continue, which includes several stages such as: international public consultation, proceedings before the Superintendence of Industry and Commerce (SIC in Spanish) and the Administrative Department of Public Administration (DAFP in Spanish) on the draft technical regulation, and proceedings before the Legal Department of the Ministry for the issuance of the final version of the technical regulation.
All of the above will allow making the required adjustments to the text, with due technical justification, prior to the implementation of the standard.
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