1. Regulatory Authority & Framework
Cosmetics in Mexico are regulated by:
- Ley General de Salud (General Health Law)
- Reglamento de Control Sanitario de Productos y Servicios
- Normas Oficiales Mexicanas (NOMs) for labeling and claims
- COFEPRIS (part of the Ministry of Health)
Mexico uses a post-market notification model but with important compliance elements:
⚠️ NO pre-market cosmetic registration certificate is required for most cosmetics.
But labeling, ingredient safety, GMP, and product claims must comply with COFEPRIS laws, and documentation must be kept for inspection.
2. Definition of Cosmetic (P&B Category)
Cosmetic = substance intended to be applied to external body parts for:
- Cleaning
- Perfuming
- Appearance modification
- Skin/hair maintenance
- Protection
If the product claims therapeutic effects → it becomes a Health Product (Medicamento / Dispositivo Médico / Suplemento) and requires full COFEPRIS registration.
3. Registration Requirements in Mexico
Mexico is similar to Canada and Australia:
📌 Most cosmetics DO NOT require a COFEPRIS registration certificate.
Instead, companies must comply with:
- Labeling NOM
- GMP
- Ingredient safety
- Claims regulations
- Import requirements
- PIF-like documentation stored and available on request
There is no CPNP-style portal, no pre-market approval.
4. When Is COFEPRIS Authorization Required?
You must obtain a COFEPRIS Sanitary Registration only if the product makes functional/therapeutic claims, such as:
- Acne treatment
- Hair growth / anti-hair loss
- Anti-dandruff
- Melasma treatment
- Exfoliating agents with strong actives
- Anti-inflammatory products
- SPF products making therapeutic claims
These are regulated as:
| Claim | Category |
|---|---|
| Treat acne | Medication |
| Hair growth | Medication |
| Anti-dandruff | Cosmetic-drug hybrid |
| Sunscreens (SPF) | Health Product requiring registration |
| Melasma treatment | Medication |
| Whitening with drug-like mechanism | Medication |
Regular cosmetic claims DO NOT require registration.
5. Documentation Required (Kept Internally, Not Submitted)
Equivalent to a Product Information File (PIF):
- Formula with percentage
- Raw material specifications
- Safety/toxicology assessment
- Microbiological test results
- Stability studies
- Manufacturing GMP (ISO 22716 recommended)
- Packaging compatibility study
- Label artwork
- Claims substantiation
COFEPRIS may request the file at any time.
6. Ingredient Restrictions (Mexican Standards + International References)
Mexico does not have its own negative/positive cosmetic lists.
It references:
- International standards (EU, U.S., Mercosur)
- NOM-SSA1 standards for chemical substances
- Mexican consumer product safety laws
Prohibited ingredients include:
- Hydroquinone (for cosmetic use)
- Mercury compounds
- Prescription-grade retinoids
- Hormones
- Steroids
- High-level salicylic acid
- Strong bleaching chemicals
Many ingredients follow EU Annex II/III restrictions in practice.
7. Labeling Requirements – NOM-141-SSA1/2012
Mexico has strict mandatory labeling rules:
Labels must include:
- Product name & function (Spanish mandatory)
- Ingredient list (INCI)
- Country of origin
- Manufacturer/importer name & address
- Batch/lot number
- Net content
- Manufacturing date / expiry date (if applicable)
- Warnings (restricted ingredients)
- Directions for safe use
- Children’s product warnings
- Claims must be truthful & verifiable
Spanish language is mandatory.
Imported products may use sticker labels, but must be compliant.
8. Importation Requirements for Cosmetics
To import cosmetics into Mexico:
- COFEPRIS Sanitary Import Notice (Aviso de Importación) may be required (varies by product)
- Commercial invoice & packing list
- Certificate of Free Sale (CFS) from country of origin (requested by some importers)
- Spanish-compliant label
- GMP compliance
- Customs inspection
COFEPRIS may sample and test imported shipments.
9. Post-Market Surveillance (PMS)
COFEPRIS performs:
- Market inspections
- Label reviews
- Laboratory testing (microbiology & heavy metals)
- Advertising monitoring
- Enforcement actions (suspensions, fines, product seizures)
Companies must:
- Maintain technical documentation
- Correct non-compliance quickly
- Conduct recalls if required
10. Borderline Products (Cosmetic vs Therapeutic)
| Product Type | Mexico Classification | Notes |
|---|---|---|
| Whitening creams | Cosmetic | Avoid melasma/medical claims |
| Sunscreens | Health Product | Requires COFEPRIS registration |
| Anti-acne | Health Product | BPO, strong SA not cosmetic |
| Hair dyes | Cosmetic | Label warnings required |
| Anti-hair loss | Health Product | Not cosmetic |
| Anti-dandruff | Health Product | Requires registration |
| Sheet masks | Cosmetic | Subject to labeling NOM |
| Strong exfoliants | Depends | May require registration |
11. Consulting Notes for Your Portfolio
| Product | Mexico Category | Notes |
|---|---|---|
| Whitening serum | Cosmetic | Avoid “treats hyperpigmentation” claims |
| Sunscreen | Requires COFEPRIS registration | SPF labeling rules apply |
| Anti-acne | Health Product | Cannot classify as cosmetic |
| Hair growth tonic | Health Product | Drug pathway |
| Sheet masks | Cosmetic | Must comply with NOM-141 labeling |
| Hair dyes | Cosmetic | Must follow consumer safety rules |
12. Advantages of the Mexican Cosmetic Market
- No pre-market cosmetic registration → fast market entry
- Spanish labeling only (simple for LATAM)
- Strong demand for Asian skincare & K-beauty
- Large urban cosmetic consumer base (CDMX, Guadalajara, Monterrey)
- Gateway to Latin America (shared supply chains with Colombia, Chile, Peru)