The cosmetics market is one of the most dynamic and promising industries worldwide. As a result, many companies dream of taking their products to other countries and expanding their reach. However, for this to happen in a legal and safe manner, it is essential to understand how cosmetic registration works at a global level.
Each country or economic block has its own specific rules for the commercialization of cosmetics. This directly impacts the level of regulatory requirements, the documentation needed, and the inspection and enforcement processes.
Even so, all markets share a common goal: to protect consumer health and ensure that cosmetic products are safe, effective, and properly labeled.
If you are considering taking your product to new markets, being well informed is essential.
That is why, in this article, we will provide an overview of how cosmetic registration works in the world’s main markets.
In addition, we will highlight what these markets have in common and how you can start structuring your export strategy.
United States (FDA): a system with clear requirements
In the United States, cosmetics are regulated by the FDA (Food and Drug Administration), one of the most influential regulatory agencies in the world.
For many companies, the U.S. cosmetic registration system is considered more flexible, but that does not mean an absence of rules.
In fact, the FDA does not require premarket cosmetic registration before commercialization, as is the case with drugs.
However, the agency expects companies to follow good practices and take full responsibility for the safety of their products.
No formal registration, but clear responsibilities
Any company that wishes to sell cosmetics in the U.S. must ensure that the product:
- It is safe for its intended use.
- Does not contain prohibited ingredients (such as chlorofluorocarbons, for example).
- It is properly labeled, including the ingredient list, manufacturer name, and required warnings.
- It is not adulterated or misleadingly labeled, under the risk of FDA enforcement action.
The FDA may conduct inspections, request product recalls, and apply sanctions in cases of noncompliance.
MoCRA in the U.S. regulatory landscape
When discussing cosmetic registration in the United States, there is a legal foundation that governs the entire system: MoCRA.
The Modernization of Cosmetics Regulation Act (MoCRA) is the law that modernized cosmetic regulation in the United States, expanding the authority of the Food and Drug Administration (FDA) over the sector. The law was enacted in 2022 as part of the Consolidated Appropriations Act, 2023.
MoCRA introduced new requirements for manufacturers and responsible parties of cosmetic products marketed in the country, with a focus on greater transparency, traceability, and safety monitoring.
Among MoCRA’s main requirements are:
- Mandatory registration of facilities that manufacture cosmetic products;
- Notification of cosmetic products to the FDA;
- Implementation of Good Manufacturing Practices (GMP);
- Maintenance of documentation related to product safety.
Difference between cosmetics and drugs
One important aspect of the U.S. market is the concept of over-the-counter (OTC) drugs.
In the United States, some products that are considered cosmetics in Brazil or Europe may be classified as drugs if they make therapeutic claims.
For example, an anti-acne cream is considered a cosmetic product in Brazil, but it may be classified as a drug in the U.S.
For this reason, it is essential to understand how your product will be classified by the FDA before placing it on the U.S. market.
Exporting and compliance
For companies looking to export to the United States, the key takeaway is this: even though cosmetic registration is not mandatory, strict compliance with FDA requirements is essential.
Unsafe products, improper labeling, or the use of prohibited ingredients may result in products being denied entry into the country or even recalled if they are already on the market.
European Union: focus on safety and traceability
When it comes to cosmetic registration, the European Union is considered one of the most rigorous and well‑structured markets.
All member countries follow the same legal framework: Regulation (EC) No. 1223/2009. This regulation establishes detailed criteria for the manufacturing, importation, and commercialization of cosmetic products in the region.
Within this system, there is no formal cosmetic registration process. However, a product may only be placed on the market after completing mandatory steps that ensure its safety and traceability.
What is required for cosmetic registration in Europe?
Before launching a cosmetic product on the European market, it is necessary to ensure:
1. Appointment of a Responsible Person
Any company that manufactures or commercializes cosmetics in the European Union but is based outside the block must appoint a Responsible Person.
This individual or legal entity will be responsible for:
- Ensuring the product’s compliance with the regulation;
- Maintaining the technical documentation (PIF);
- Notifying authorities of incidents, when necessary.
2. Preparation of the PIF (Product Information File)
The PIF is a mandatory technical dossier that includes:
- Cosmetic safety report;
- Product description;
- Manufacturing methods;
- Evidence supporting claimed effects;
- Toxicological data of the ingredients.
The PIF must be kept available for inspections for 10 years after the product is last placed on the market.
3. Notification in the CPNP (Cosmetic Products Notification Portal)
Before entering the market, the product must be notified through the CPNP, a European electronic portal that allows authorities from all member countries to access product information.
Ingredients, testing, and labeling
In addition to these requirements, the European Union cosmetic registration system has other specific features.
To begin with, the EU maintains clear and regularly updated lists of prohibited and restricted ingredients.
Regarding product testing, a total ban on animal testing for cosmetics and cosmetic ingredients is in force. This restriction also affects companies based outside the EU that wish to export to the bloc.
Finally, there are labeling requirements. All cosmetics must have complete and compliant labeling, including: the name and address of the Responsible Person; batch number; ingredient list (INCI); expiration date (when applicable); and mandatory warnings. All information must be provided in the official language of the country where the product is sold.
A rigorous but predictable system
The European Union’s main advantage is that, although the requirements are detailed, they are clear, standardized, and transparent.
This makes planning easier for companies that wish to export, provided they are willing to comply with the requirements carefully and in an organized manner.
Brazil (Anvisa): notification, registration, and basic requirements
In Brazil, the authority responsible for cosmetic regulation is Anvisa (the Brazilian Health Regulatory Agency).
Anvisa defines the rules for the manufacturing, commercialization, and importation of personal care products, cosmetics, and perfumes through RDC No. 907/2024.
An interesting point is that if you are a Brazilian manufacturer planning to export to other countries, national compliance is often the first step toward issuing certificates such as the Free Sale Certificate (FSC), which is required by many international markets.
Anvisa classifies cosmetics into two categories, based on the level of risk they pose to consumer health:
Category 1 – Products with basic properties
This category includes products such as shampoos, liquid soaps, standard deodorants, moisturizing creams, among others.
These products do not require formal registration.
In practice, the manufacturer or importer only needs to submit an electronic notification through Anvisa’s system (the Notification System for Personal Hygiene Products, Cosmetics, and Perfumes).
Once notified, the product may be commercialized. However, it remains subject to inspection, particularly regarding labeling compliance, adherence to Good Manufacturing Practices, and formulation within permitted limits.
Category 2 – Products with specific indications
This category includes products with more specific or sensitive functions, such as sunscreens, hair straightening products, skin lighteners, and children’s cosmetics.
These products must undergo a more rigorous review process by Anvisa, which includes:
- Submission of technical documentation;
- Evidence of safety and/or efficacy.
In fact, these products must be either notified or registered, depending on their intended use.
An important detail is that cosmetic registration in Brazil is valid for 10 years and must be renewed before the end of this period.
Common information and requirements
Regardless of the category, all cosmetics must comply with some basic rules for cosmetic registration and regularization in Brazil:
- Use only ingredients permitted by Anvisa and within authorized concentration limits;
- Be properly labeled (including expiration date, company tax ID number (CNPJ), country of origin, directions for use, and mandatory warnings);
- Be manufactured or imported by a company that holds a valid Operating Authorization (AFE) issued by Anvisa.
Asia and Arab countries: regulatory diversity with a trend toward harmonization
Markets in Asia and the Middle East offer strong growth potential for the cosmetics industry.
This is driven by high consumer demand, local beauty trends, and a growing interest in imported products.
However, these markets also present significant regulatory diversity, requiring special attention from companies looking to export to the region.
The good news is that many of these countries are aligning their regulations with international standards, making the process more predictable and structured.
Asia: focus on safety and traceability
China
China is one of the most complex markets. Until recently, animal testing was mandatory for most imported cosmetics.
However, due to recent regulatory changes:
- “General” cosmetics (such as moisturizers or shampoos) may be exempt from animal testing, provided they meet specific requirements;
- Cosmetic registration with the NMPA (National Medical Products Administration) is required;
- Local presence through a legal responsible party is mandatory.
In addition, “special” products (such as sunscreens or hair loss treatments) are still subject to a more rigorous approval process.
Japan
Cosmetic registration in Japan follows the concept of quasi-drugs, which can affect the classification of certain products. The country requires:
- Safety and quality assessments;
- Ingredient registration and compliance with specific positive and negative lists;
- A local responsible party in Japan (authorized importer).
Despite its technical rigor, the Japanese system is considered well-structured and stable.
South Korea
South Korea is a global reference for cosmetic innovation and has a modern regulatory framework aligned with the European model. Cosmetics are divided into:
- Functional cosmetics (which require prior approval, such as skin‑whitening or anti‑aging products);
- General cosmetics, which require notification and compliance with good practices but are exempt from formal registration.
The country also requires the appointment of a legal responsible party for the product.
Arab countries: adaptation to the halal market and regional agreements
Countries such as Saudi Arabia, the United Arab Emirates, Qatar, and Oman are part of the GCC (Gulf Cooperation Council), which seeks to harmonize regulations while still maintaining variations among member states.
Some common characteristics of Gulf markets include:
- Prior product registration is often required, with submission of a technical dossier and samples (including a Free Sale Certificate);
- Halal certifications are frequently valued and, in some cases, mandatory;
- Labels must be in Arabic and include all required information.
What do markets have in common, and where should you start your international strategy?
Despite differences in legislation and cultural contexts, the main international cosmetic markets share several common principles.
Understanding these points is essential for any company looking to expand internationally in a safe and successful way.
Common principles in global cosmetic regulation:
1. Consumer safety comes first: All regulatory authorities require that cosmetic products be safe for use, based on scientific evidence and formulations that comply with the legal limits established for each ingredient.
2. Clear labeling in the local language: Labeling is a critical requirement. In general, labels must be in the official language of the country where the product will be sold and include directions for use, ingredient lists, warnings, batch numbers, and expiration dates.
3. Technical documentation accessible to authorities: Whether it is the PIF in Europe, a technical dossier in Gulf countries, or a safety file in the United States, all markets expect companies to maintain technical documentation that demonstrates the cosmetic product’s safety and quality.
4. Local legal responsible party: Most markets require the appointment of a local individual or company that is legally responsible for the product.
5. Good Manufacturing Practices (GMP): In general, authorities do not directly approve manufacturing facilities, but they do expect products to be manufactured in facilities that follow Good Manufacturing Practices. This means ensuring cleanliness, quality control, and full process traceability.
Where should you start an international strategy?
If your company wants to start exporting cosmetics, here are some practical steps to consider:
1. Choose your target market based on product fit, local demand, and regulatory requirements.
Markets with strong consumer potential but more accessible requirements can be good entry points.
2. Check how your product is classified in the destination country.
The same cosmetic product may be classified as a drug in another country, which directly impacts the regulatory process.
3. Prepare technical documentation following international standards.
Even if the country does not require formal cosmetic registration, safety documentation (technical data sheets, tests, PIF) will be useful and, in many cases, mandatory.
4. Adapt labeling to the local language and regulatory requirements.
Include all mandatory information and avoid prohibited terms or claims in the region.
5. Look for a reliable local partner.
Distributors, regulatory agents, and local consultancies can speed up processes and help ensure compliance.
Final tip
Exporting cosmetics requires more than just a good product. It demands regulatory knowledge, well‑organized documentation, and strategic planning.
That is why working with specialists in global cosmetic regulation can make all the difference.
If you want to avoid the risk of missing important details or failing to meet regulatory requirements, have Sobel by your side.
Our specialists have global expertise and are ready to guide your company through the regulatory journey of the world’s main markets.
Planning is essential
Expanding your cosmetic brand to other countries is an important step and, with proper planning, can be an excellent growth opportunity.
The key to a successful export strategy lies in:
- Studying the target market;
- Planning documentation based on local and international requirements;
- Ensuring the product is technically prepared to pass audits and regulatory reviews;
- Bonus: relying on the support of Sobel specialists.
With a careful approach, your company can enter new markets and build a reputation for quality and trust on an international level.
