Food Supplement Registration in Mexico - Overview
The Mexican nutraceutical and dietary supplement markets are rapidly growing due to rising health concerns, changing lifestyles of consumers, and increasing awareness regarding the consumption of healthy foods. The Federal Commission for the Protection against Sanitary Risk, formally known as COFEPRIS is the apex regulatory body in charge of regulations pertaining to food, food supplements, and herbal products in Mexico.
COFEPRIS is responsible for the production, distribution, commercialization, imports and exports, advertisement, sales and supply, and compliance of food products in Mexico. Under the General Health, law, the Secretariat of Health (SALUD), through its operating arm, COFEPRIS, implements and enforces sanitary regulations to protect the population against health risks. For food, food supplements, and herbal products, one must submit a “Notice of Operation," 30 days before starting operations. The products also require a Prior Sanitary Import Permit (PSPI) to enter Mexico.
Products that are classified as food supplements do not require sanitary COFEPRIS registration. To launch a compliant food supplement as per proposed regulations, the product must be checked for ingredients, labels, claims and submit consultation to COFEPRIS for the right classification. Post which, a ‘Notice of Operation' and import permits are needed to enter the Mexican market.
Freyr assists manufacturers in entering the Mexican food supplements and herbal products market compliantly, with comprehensive knowledge of food regulations in Mexico and with proven regulatory expertise in COFEPRIS registration.
Food Supplement Registration in Mexico - Freyr Expertise
- Support in Submitting Consultation, Notice of Operation, and Import Permit for Food Supplements;
- Food Product Compliance and Classification;
- Formula Review/Ingredients Assessment;
- Label and Claims Review;
- Dossier Compilation and Submission to the Health Authority (HA);
- COFEPRIS registration Support Services;
- Regulatory Intelligence (RI) Report;
- Regulatory Updates on the Guidelines/Standards;
- Local Labeling Support;
- Translation Services;
- Legal Representation (LR);
- End-to-end Support in Registering Herbal Medicines; and
- End-to-end Support for Herbal Remedy Products.
Food Supplement Registration in Mexico - Freyr Advantages
- End-to-end regulatory consultation for Mexico;
- Legal representation (LR) and local support for Mexico;
- Strong rapport and association with COFEPRIS Registration;
- Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, and many more;
- Support for region-specific regulatory activities;
- Extensive partner network across the globe; and
- A strong relationship with different Health Authorities (HA).
