Mexico is one of the largest and fastest-growing markets for skincare products in Latin America. With a population that increasingly values skincare and beauty, entering the Mexican market offers great potential for international brands. However, before your skincare products can reach Mexican consumers, it’s essential to navigate the country’s legal regulations and labeling requirements to ensure compliance and a smooth import operation. As with many other products, like textiles, it is important to follow the legal requirements and regulations when importing different products into a big market as Mexico is.
Complying with legal authorities, the documentation and regulations needed are going to become a facilitator in allowing your beauty or skincare products to undergo the import process at a more optimal time.
In this blog post, we’ll walk you through the key aspects you need to consider if you want to sell skincare products in Mexico.
Regulatory Authority: COFEPRIS
In Mexico, the primary regulatory body for health and safety, including cosmetics and skincare products, is COFEPRIS (Federal Commission for the Protection Against Sanitary Risks). COFEPRIS is responsible for regulating and reviewing the safety of products in the health, food, and cosmetic sectors. If you want to sell skincare products in Mexico, you need to comply with COFEPRIS regulations to ensure your products are safe and suitable for the market.
The most well known skincare brands like Neutrogena, Eucerin and Bioderma, to name a few, are COFEPRIS approved.
COFEPRIS oversees a range of activities, including:
- Product registration: Certain skincare products, especially those with active ingredients that affect health (such as sunscreens, anti-aging creams, or acne treatments), may require registration with COFEPRIS.
- Health and safety standards: COFEPRIS sets requirements for product ingredients, quality, and safety, making sure they meet international standards.
Skincare Product Registration in Mexico
Skincare products are mostly divided into two categories in the country: cosmetics and therapeutic products.
- Cosmetics: These are skincare products meant for beautifying, altering the appearance, or maintaining the skin’s health. Products like moisturizers, cleansers, and toners typically fall into this category.
- Therapeutic products: If your skincare product makes therapeutic claims (such as treating acne or reducing wrinkles), it could be classified as a drug or a medical device under Mexican law. These products may need to go into a more extensive review and approval process by COFEPRIS.
For cosmetic products, while registration is not always mandatory, notification to COFEPRIS is required. This notification process involves submitting a product dossier that includes details like the ingredients, manufacturing process, and intended use. For therapeutic products, you'll need formal registration, which includes clinical trials, ingredient testing, and safety evaluations.
This makes sure your products are safe for the market, and that all regulations comply, opening a gate for an increase in sales in your new beauty or skincare brand ready to expand internationally.
Labeling Requirements for Skincare Products in Mexico
Proper labeling is crucial for skincare products in Mexico. The country has strict labeling guidelines that ensure consumers have all the necessary information to make informed decisions.
These regulations aim to protect public health and provide transparency regarding product ingredients, usage, and safety. The labeling and documentation standards are also in place to prevent misleading claims and ensure that products are suitable for the specific needs of Mexican consumers.
Here are the key labeling requirements you must follow:
a. Language Requirement
All product labels must be in Spanish. This includes not only the main label on the product but also any additional packaging or promotional materials. Check that all ingredients, instructions, warnings, and usage information are clearly stated in Spanish.
If the skincare or beauty product does not have a Spanish labeling, sales will not be able to take place. The best option is to approach a customs broker service and undergo the process of translating the labels that are needed. Doing this before the import operation will facilitate the process and ensure the new market trusts the brand.
b. Required Information on the Label
Skincare products must include the following information on the label:
- Product name: This should be clear and descriptive, indicating the product’s function.
- Ingredients: A complete list of ingredients used in the formulation must be included. Ingredients must be listed in descending order of concentration.
- Net content: The amount of product inside the container must be specified in metric units (grams or milliliters).
- Manufacturer or distributor details: Include the name, address, and contact information for the manufacturer, distributor, or the importer of the product.
- Expiration date: If the product has a shelf life of less than 30 months, it must have an expiration date or a "best before" date.
- Instructions for use: The label must include clear instructions on how to use the product properly.
- Precautions or warnings: If necessary, include any safety warnings (e.g., for sensitive skin, avoid eye contact, etc.).
- Registration or notification number: For regulated skincare products, the COFEPRIS notification or registration number should be visible on the label.
- Language: Everything must be written in Spanish with wording that the Mexican Market can understand.
c. Claims and Advertising
Be cautious with claims on the packaging and advertising. Any claim that your product treats or cures a skin condition ( like "acne treatment" or "wrinkle removal") could cause the product to be reclassified as a drug by COFEPRIS. If your product falls into this category, you’ll need additional approvals, clinical data, and more extensive regulatory analysis. Claims related to beauty benefits (like "moisturizing" or "anti-aging") are typically acceptable for cosmetics, as long as they are not misleading.
d. Barcodes and Compliance
All products must have a barcode for tracking and sales purposes, especially if they are being sold in retail stores. Ensure that your packaging complies with the local standards for barcodes and product identification.
A barcode system also comes in handy if you are planning to work with a fulfillment partner that ensures the products are delivered to the final consumer on time and place.
Importation Requirements
If you are planning to import your skincare products into Mexico, you must follow the country’s import regulations. The process typically involves:
- Customs clearance: All shipments will need to clear customs before they can enter the market. This process includes ensuring your products comply with labeling and safety requirements.
- Import permits: Depending on the product category, you may need an import permit from COFEPRIS or other relevant authorities.
- Taxes and tariffs: Import duties and taxes must be considered when calculating the cost of bringing your skincare products into Mexico. Ensure that you are up-to-date with the latest trade agreements, like the USMCA (United States-Mexico-Canada Agreement), which may affect import fees.
Navigating these requirements can be complex, especially if you are unfamiliar with the local regulatory environment. Import experts can play a critical role in helping you successfully import your skincare products into Mexico. These professionals are well-versed in COFEPRIS regulations, customs procedures, and the necessary documentation. They can guide you through the process of obtaining import permits, ensuring proper labeling, and calculating applicable tariffs and taxes. Their expertise can save you time and help avoid costly mistakes, ensuring that your products enter the market smoothly and efficiently.
Testing and Clinical Trials (for therapeutic claims)
If your skincare product makes any therapeutic claims, such as curing or treating skin conditions, you will need to provide evidence of the product’s safety and efficacy. This often involves conducting clinical trials or dermatological testing. COFEPRIS will require detailed reports of these studies to assess the product’s safety and performance before granting approval.
Cruelty-free products that don't test in animals are more likely to be a market favorite. According to Mexico Business, 54% of consumers are switching to plant-based, cruelty free products.
Compliance with International Standards
Finally, it’s important to ensure that your skincare products meet international quality standards. This includes standards set by organizations like the ISO (International Organization for Standardization) and the GMP (Good Manufacturing Practices). Adhering to these standards can help ensure the safety and quality of your products, making them more attractive to both consumers and regulatory authorities in Mexico.
Additionally, meeting these global standards can boost the credibility of your brand in the competitive Mexican market, as consumers are becoming more informed and cautious about the products they use. By demonstrating your commitment to high-quality production processes, you can build trust and increase your brand’s reputation, which is essential for long-term success in the region.
Conclusion
Selling skincare products in Mexico can be an exciting and profitable venture, but it’s crucial to understand the legal and regulatory landscape. From complying with COFEPRIS regulations to meeting labeling requirements and providing proper documentation, careful planning is key to ensuring your products make a smooth entry into the market.
By adhering to these guidelines, you not only protect your brand but also build trust with consumers and ensure that your products are safe, effective, and in line with Mexican regulations.
Successfully navigating the Mexican market requires attention to detail, patience, and the right partnerships. With a solid understanding of local requirements and a proactive approach to compliance, your skincare brand will be well-positioned for long-term success.
A footnote from Cubbo
Ready to expand into Mexico? Be sure to consult with logistics experts or local representatives to guide you through the regulatory process and help your skincare brand thrive in this dynamic market!
