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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