What is NOM-141 and why does it matter?
NOM-141-SSA1/SCF1-2012 is the Mexican Official Standard that governs cosmetic labeling and ingredients. It's the foundation of COFEPRIS compliance — and 38% of cosmetic rejections in Mexico are due to NOM-141 labeling violations.
Mandatory label elements under NOM-141
Every cosmetic sold in Mexico must have a label in Spanish containing:
- Nombre del producto y marca — Product name and brand
- Lista completa de ingredientes — Complete ingredient list in descending order
- Contenido neto — Net content in metric units (g, mL, L)
- País de origen — Country of origin
- Nombre y domicilio del representante legal — Mexican legal representative name and address
- Número de Registro Sanitario — After approval
- Número de lote — Batch/lot number
- Fecha de caducidad o P.A.O. — Expiration date or Period After Opening symbol
- Avisos de precaución — Required warnings for specific categories
Language requirements
100% Spanish. No exceptions. Common mistakes that lead to rejection:
- Leaving "Net Wt." or "Made in USA" in English
- Using bilingual labels (Spanish + English)
- Mixing Spanish with INCI names incorrectly
Best practice: Use professional regulatory translators who understand cosmetic terminology. Machine translation is not acceptable for COFEPRIS.
Ingredient disclosure rules
- Descending order by concentration
- INCI nomenclature for international consistency
- Ingredients ≤1% may be listed in any order after higher-concentration ingredients
- Color additives: Must include CI number
- Fragrance allergens: COFEPRIS requires disclosure of specific allergens (similar to EU Regulation 1223/2009)
Product-specific warnings
| Product Type | Required Warning (Spanish) |
|---|---|
| Tintes para cabello | "Contiene ingredientes que pueden causar reacciones alérgicas" |
| Productos con AHA/BHA | "Use protector solar durante y después del uso" |
| Productos para niños | "Uso bajo supervisión de adulto" |
| Protectores solares | Valor SPF, protección UVA, instrucciones de reaplicación |
| Uso externo | "Uso externo. No ingerir" |
NOM-141 vs ANVISA labeling: key differences
| Aspect | NOM-141 (Mexico) | RDC 375 (Brazil) |
|---|---|---|
| Language | Spanish | Portuguese |
| Units | Metric only | Metric only |
| Allergen disclosure | Required (EU-style) | Required |
| Local rep name | Legal representative | PTR (pharmacist) |
Label verification checklist
- [ ] 100% Spanish text
- [ ] Metric units (g, mL, L)
- [ ] Complete ingredient list (INCI)
- [ ] Registro Sanitario number
- [ ] Legal representative name and address
- [ ] Batch number and expiration date
- [ ] Required warnings for product category
- [ ] No therapeutic claims