Mexico City, February 10 2025
On February 4, 2025, the Ministry of Economy published the 2025 National Quality Infrastructure Program, which includes a modification to section 4.5.3 of NOM-051-SCFI/SSA1-2010 on labeling prepackaged food and non-alcoholic beverages.
This modification follows an economic and health impact analysis conducted by the Ministry of Economy and COFEPRIS, which concluded that implementing the Third Phase would impose a greater burden on regulated entities than the benefits already achieved under the current implementation.
Meanwhile, on January 23, 2025, COFEPRIS announced that it would formally analyze the use of FD&C Red No. 3 in food, beverages, and pharmaceuticals following the FDA’s decision to revoke its authorization.
The ongoing changes and analyses may have the following key implications:
1. Labeling Regulations:
- Updates to criteria for evaluating critical nutrients.
- Modifications to the calculation of added nutrients.
- Adjustments to the front-of-package labeling system.
- Potential elimination of the planned Third Phase.
2. Additive Regulations:
- Risk assessment of FD&C Red No. 3 based on its established ADI.
- Review of Annex III – Colorants of the Additives Agreement.
- Evaluation of the FEUM colorant list for pharmaceuticals.
- Potential updates to health requirements.
3. Industry Impact:
- Need to review current specifications.
- Possible modifications to labels and formulations.
- Updates to verification processes.
- Cost implications for implementation.
Failure to address these changes could result in regulatory non-compliance, administrative sanctions, and challenges in marketing products in the domestic market.
At Basham, our regulatory law specialists can help you assess the impact of these modifications on your products, update labeling and technical documentation, implement necessary changes in your processes, and ensure ongoing regulatory compliance.
Our interdisciplinary team is available to conduct a detailed analysis of your products and develop an effective compliance strategy.
Sincerely,
Adolfo Athié Cervantes
Diana Rangel León
Daniela Pineda Robles
Ricardo Antonio Tagle Pastén
