LIFE SCIENCES NEWSLETTER
Digemid modifies regulations related to the person in charge of pharmacovigilance
By means of Ministerial Resolution 49-2025/MINSA, one (1) article of the Good Pharmacovigilance Practices Manual was modified. This modification eliminates the labor relationship with the person in charge of pharmacovigilance.
Peruvian position regarding red dye 3
Through Communiqué 1-2025, Digesa informs the following:
- International background: The FDA of the United States determined that red dye 3 causes cancer in male rats exposed to high doses, although there is no conclusive evidence in humans. Therefore, it has set January 15, 2027 as the deadline for U.S. manufacturers to reformulate their products.
- Situation in Peru: DIGESA assures that in the country no foodstuffs have been registered that exceed the limits established by the FDA and the Codex Alimentarius for this colorant.
- Recommendation to the food industry: Despite not having conclusive evidence in humans, DIGESA suggests to start a progressive replacement of red 3 by natural additives, with a deadline until January 15, 2027.
- Next steps: The Ministry of Health has commissioned INS/CENAN to conduct a comprehensive review of the available scientific evidence to assess possible additional risks associated with the use of the colorant.
The food industry should be vigilant with regard to the draft on genetically modified ingredients
By Ministerial Resolution N° 010-2025-PCM, the “Draft Supreme Decree approving the Technical Regulation on Labeling of Genetically Modified Foods” (hereinafter referred to as the Draft) was published.
According to the Draft, it will be mandatory to include in the labeling the phrase “Genetically Modified Food” or “GM Food”, indelibly or through the use of an adhesive, when the following assumptions are met in packaged foods:
- They are available to final consumers at points of sale in the national territory or are intended for catering purposes (used in restaurants, canteens, schools, hospitals and similar institutions where meals are prepared for immediate consumption).
- They are included in the list in Annex 1.
- The percentage of genetically modified components or ingredients exceeds the tolerance threshold of 3%.
The Draft is subject to review and there is a period of ninety (90) calendar days for INDECOPI to receive comments, contributions or opinions from public and/or private entities and the general public.
For further information on the Draft: https://www.estudiorodrigo.com/en/life-sciences-alert-january-2025/
