Normal cosmetic products do not need to be registered before entering the market. But companies have the responsibility to make sure that their products meet all the applicable labeling, safety, and Good Manufacturing Practice (GMP) requirements before they are put into commerce.
NOM-141-SSA1/SCFI-2012 is the standard that establishes the requirements for labelling of prepackaged cosmetic products in Mexico, both of national origin and imported.
In Mexico, the General Health Law and sanitary regulations are applied to the regulation of cosmetics by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
Read this blog to understand how to stay complaint with COFEPRIS regulations and all the Mexico cosmetics labeling requirements.
Mexico Cosmetics Labeling Requirements under NOM-141-SSA1/SCFI-2012
NOM-141-SSA1/SCFI-2012 establishes the general requirements for the labelling of cosmetic products marketed in Mexico, as follows:
Product Name
The name of the product should contain sufficient information on the nature and cosmetic application of the product. Label information shall not mislead consumers when it comes to the product’s characteristics and intended use.
Ingredient Declaration
The list of ingredients should be on the label. Ingredients are typically shown by the most abundant first, followed by those quantities that are smaller. Ingredients are also often listed according to the common name, and in addition, when the common name is not adequate, often by the accepted international INCI name (where applicable).
Precautions regarding ingredients that could cause a health issue should be included in Spanish.
Net Quantity
Must be in a metric unit (e.g., g – grams, kg – kilograms, mL – millilitres, or L – litres).
Manufacturer or Importer Information
The label should contain the name and address of the company responsible.
A local importer or distributor of information in Mexico is usually required for importing cosmetics for traceability and distribution.
Country of Origin
It is necessary that imported products state the country of origin.
Examples include:
- Made in France
- Manufactured in Korea
- Product of the USA
Batch or Lot Number
A batch number or similar (lot number) must be included in products for post-market traceability and to aid quality control.
Expiration / Durability Information
For cosmetic products, expiration or minimum durability should be used if applicable, particularly when considering cosmetics that are not recognized as having a long shelf life or stability.
Instructions for Use
If special instructions on the application are required, the instructions should be in the product to ensure safe and effective use.
However, it is crucial for:
- Hair dyes
- Sunscreens
- Professional-use cosmetics
- Exfoliating products
Warnings and Precautionary Statements
All necessary warning(s) or precaution(s) which should be included for use of the product should be prominently displayed on the label with translation in Spanish (as needed).
Depending on what they are made of and what they are used for, some cosmetics might need to be further labelled as they pose more severe risks.
In addition to the general requirements, NOM-141-SSA1/SCFI-2012 contains specific requirements for products like children’s products, fragrances, oral care products, hair dyes, and sunscreens.
Sunscreen Products
Sunscreen-containing products need to include information related to sun protection, as well as instructions on the protection and correct use of the sunscreen product.
Hair Dye Products
Healthcare warnings are usually found on hair dyes about allergic response, and patch testing or sensitivity warning before using the dye.
Toothpastes
Fluoride content must be identified in products using toothpaste by reference to applicable requirements.
Products Intended for Children
Precautionary statements: For products to be used by children, use statements and precautions should address accidental ingestion and safe use (only if relevant).
As of today, in Mexico, all cosmetics marketed should meet the requirements of labeling as stipulated in NOM-141-SSA1/SCFI-2012. The competent authorities may observe non-compliance, which may lead to delays in imports, corrective actions, or other enforcement actions.
Additional Considerations for Cosmetic Labeling Compliance in Mexico
There are further points to consider if your cosmetic products are to be sold in Mexico. If you’re packaging cosmetics for sale in Mexico, these are some more points you should consider.
The following best practices should also be taken into account when companies market cosmetics in Mexico:
- Present labels in a clear, easily read, and consumer-friendly text
- Make sure that the Spanish language labelling requirements are met
- Ensure the product design, technical literature, and formulation information are all consistent
- Carefully analyse the statements used for cosmetics, don’t position them as medicinal or therapeutic
- Make sure warnings and cautionary words are correctly translated
- Have labels checked by regulators and experts in COFEPRIS requirements
Supplements are often needed for Spanish-language labelling prior to commercialization in Mexico for imported products. One of the most often found packaging problems when entering the Mexican market is that the global packaging art is not the same as expected for the Mexican market.
One of Mexico’s most attractive business opportunities is the cosmetics business. Get to know our COFEPRIS regulatory affairs services to label cosmetic products and comply with GMP.
The Mexico COFEPRIS Good Manufacturing Practices (GMP) Requirements for Cosmetics
NOM-259-SSA1-2022 establishes Good Manufacturing Practice (GMP) requirements for Cosmetics in Mexico. The sanitary and operational controls for personnel, facilities, and equipment, production, storage, transportation, documentation, quality systems, and traceability are covered in the regulation.
The establishment of regulation is applicable to any establishment that produces, conditions, imports, and commercializes cosmetic products in Mexico. It also extends to imported products – if and when an importer imports their products into Mexico, they have to store information about manufacturing, traceability, and quality controls.
Personnel
Staff working in cosmetic production, storage, conditioning, or quality control should be aware of the need to maintain hygiene and health, to minimise the risk of contamination in production, storage, conditioning, and quality control.
Jewelry and unnecessary personal items should not be worn in operational areas. Those who exhibit high-risk illness (HRD) that may impact product quality should not be involved in product manufacturing with exposed materials or products.
Personal items, eating, and smoking are limited in manufacturing/storage areas. GMP training of staff should also be updated on a regular basis, regarding hygiene standards, use of personal protective equipment (PPE), preventing contamination, and operating procedures. Where controlled areas are present, it will be required that visitors adhere to facility hygiene and protective clothing requirements.
Physical Facilities
The production, conditioning, storage, and quality control tasks should be conducted in an area that is properly segregated and designed for such activities.
It is important that facilities offer enough space for moving materials, cleaning up, and moving workers in the facility, as well as controlling contamination.
Sanitary Facilities
Good, separate, well-maintained restrooms and change areas should be provided outside of production areas.
Hand cleaning stations include soap, drying materials, and waste bins. Reminders about hygiene are frequently hung in places or areas where hands should be washed before re-entering areas of operation.
Services
Potable water should always be available at the facilities for cleaning and sanitisation purposes and for the use of employees.
Regular maintenance and monitoring of water storage and distribution systems should be done.
Cleaning of Equipment, Maintenance, Pest Control, and Waste Management
The cleaning and sanitation of equipment are most critical to ensure manufacturing environments are sanitary, and contamination does not occur.
Documented cleaning procedures should be performed when equipment is being used continuously or for a variety of products, and it is important to avoid potential contamination and minimise product carryover.
Retrieval of equipment for maintenance or repair should not compromise the quality of the product. Inspecting equipment after maintenance/repair, prior to return to use, should not compromise the quality of the product.
Pest control includes a whole establishment approach to prohibit insects, rodents, domestic animals, and other pests. Waste management systems should include regular waste collection, identification, storage, and disposal of waste materials without interfering with the production processes or lab operations.
Equipment, Accessories, and Utensils
Equipment must be correctly designed, installed, maintained, and identified for its intended purpose without compromising product quality.
The materials that come in contact with raw materials, bulk material, or finished material should not react with or have negative effects on the product.
It is important to clean and prepare transfer hoses, utensils, and accessories to reduce the risk of contamination. Access to fixed equipment should be sufficient for cleaning, operation, and maintenance.
Calibration
Quality control and manufacturing equipment, measuring and monitoring used, should be calibrated in accordance with SOPs.
Equipment that doesn’t meet calibration requirements should be identified and taken offline for correction. An investigation should also examine the possibility of wrong measurements influencing the quality of the product.
Raw Materials and Packaging Materials
All materials used as raw and packaging materials shall be received, checked, identified, and stored as per the procedures.
Materials should satisfy specific acceptance criteria and specifications prior to use in manufacturing. Containers should be well labelled and shielded from deterioration, contamination, and environmental exposure.
The results of inspection may lead to materials being categorized as accepted, quarantined, or rejected. Stock rotation principles should be adhered to, where available, the “First in, First out” (FIFO) principle. Flammable materials (where necessary) should be treated and stored in a particular way.
Production
Production activities should be documented to ensure the consistency, quality, and traceability of products from source to source in manufacturing.
In the pre-production phase, companies need to ensure:
- Various documents were necessary
- The date when the raw material is released for temporary use
- Equipment is clean and in proper condition
- Materials taken out of operations in the past
There was an attempt to give each production batch an Identification code for tracing.
Care should be taken in packaging and filling to reduce the contamination of packaging, labelling inaccuracies, and product confusion. Labeling and storage of finished products must be appropriate until they are released by authorized personnel.
Transportation
Products should be moved in a manner that will prevent contamination, deterioration, or environmental exposure, which may contribute to product contamination or diminish its quality attributes.
Transportation vehicles should be maintained in good condition, and they should be made using materials appropriate to cosmetic products.
Quality Control
QC activities should be conducted by following the approved Company procedures and methods.
Any variation from the specification should be investigated by the authorized personnel. Documentation and justification of re-analysis, reprocessing decisions, and corrective actions should be recorded.
Reprocessed Finished Products and Bulk Products
Rejection, reprocessing, or disposal of finished or bulk products, in case of failure to comply with the specified requirements, should be performed in accordance with documented quality procedures.
Products must then be re-evaluated upon reprocessing to ensure conformance with product specifications and the criteria of acceptance.
Complaints, Returns, and Withdrawals
Complaint treatment processes, returns and investigations procedures, and product withdrawals procedures should be in place for companies.
Rashes, allergens, or issues in which the adverse reaction safety of the product is an issue should be looked into, documented, and treated properly if a complaint is made.
Before a decision can be made on reusing, destroying, or additional evaluations, returned products should be evaluated on certain defined criteria.
The companies should have systems in place that comply with a prompt and efficient recall procedure if the product needs to be withdrawn. In the event that there is a potential risk to public health, competent authorities should be informed.
Documentation for Cosmetics Labeling for COFEPRIS in Mexico
Documentation systems should be kept in Spanish and presented in an easily accessible, readable, and understandable way.
Records should state their purpose, indicate if they have been revised, include who is responsible, and provide approval of information, if applicable.
Businesses should keep the records for the periods prescribed under corresponding rules or regulations and make available to health authorities for operational records, procedures, and supporting records as required upon their request.
Conclusion
The Cosmetic Industry Companies can benefit from early implementation of NOM-141-SSA1/SCFI-2012 and NOM-259-SSA1-2022, not only to reduce the delays that Mexican Customs may cause while importing certain products. It can also help reduce efforts that are not necessary for the commercialization of cosmetics in Mexico. Since it is likely that product quality will not be compromised.
Provide appropriate guidance, training, and training support with product labelling, Good Manufacturing Practice (GMP), and other regulatory requirements, including COFEPRIS for sale and distribution in Mexico.
