International Cosmetics Compliance: Global Regulatory Guide Including MoCRA, REACH, BIS

Expanding into international cosmetic markets requires more than product innovation. It demands precise regulatory compliance across global authorities, which are regulatory bodies that regulate cosmetics under specific laws in various countries, including the United States (MoCRA), the EU (REACH), India (BIS), and emerging systems in China, Japan, the UAE, Africa, and Southeast Asia. Safety substantiation is a core requirement for international cosmetics compliance, ensuring that products meet the necessary safety standards in each market.

This B2B guide provides an updated breakdown of key regulatory frameworks and laws across various countries, offering insights into label and formulation compliance for brands scaling globally. It helps brands understand how each authority regulates cosmetics well, ensuring comprehensive awareness of international requirements.

Introduction to Cosmetic Regulations

The cosmetics industry operates within a complex web of regulations designed to protect consumer health and ensure product quality. In the United States, the Food and Drug Administration (FDA) oversees cosmetic products under the Federal Food, Drug, and Cosmetic (FD&C) Act, setting out clear requirements for safety, labeling, and manufacturing. Similarly, the European Union enforces a robust regulatory framework through Regulation (EC) No 1223/2009, which forms the backbone of EU cosmetics legislation.

While cosmetic regulations differ from country to country, most require that manufacturers and distributors ensure their products meet strict safety and quality standards. This includes adherence to Good Manufacturing Practices (GMP), accurate and compliant labeling, and the appointment of a responsible person to oversee regulatory compliance.

Adverse event reporting is also a key regulatory requirement in many jurisdictions, helping authorities monitor product safety after cosmetics reach the market. Whether operating in the United States, the European Union, or other global markets, companies must stay informed about evolving legislation and ensure their cosmetic products are manufactured, labeled, and marketed in accordance with all applicable laws and regulations.

Summary Comparison Table: Core Regulatory Bodies

Note: Across all regions, regulatory authorities require thorough safety assessment, cosmetic ingredient compliance, and product safety documentation as essential components of international cosmetics compliance.

USA – MoCRA (Modernization of Cosmetics Regulation Act)

• All cosmetic products must comply with MoCRA requirements to be legally marketed in the USA.
• FDA-registered facility required
• Mandatory product listing + formula disclosure
• Substantiated safety data required
• Adverse Event Reporting (AER) is now mandatory
• Marketing claims must avoid drug-like language
• Managing time effectively is crucial to meet MoCRA registration and compliance deadlines.
• Using FDA digital systems and GMP protocols can streamline compliance and ensure product safety.

EU – Cosmetics Regulation + REACH

• Appoint an EU-based Responsible Person (RP)
• Notify the product via the CPNP portal
• Maintain Product Information File (PIF), including a comprehensive safety assessment as a mandatory component
• Comply with restricted/banned cosmetic ingredient lists
• Provide clear INCI labelling and usage instructions, ensuring a detailed list of ingredients is present on the product label for compliance

India – BIS + CDSCO Rules

• Facilities that manufacture cosmetics in India must comply with IS 4707 Part 1 & 2 and other relevant laws governing cosmetic products.
• Importers must register products with the CDSCO.
• Labeling must include MRP, batch number, and shelf life.
• Animal testing is banned.
• A full ingredient list in descending order is required, and all ingredients used in the product must be listed in accordance with Indian law.

China – CSAR (Cosmetic Supervision and Administration Regulation)

• Requires pre-market safety assessments and raw material data, including cosmetic ingredient registration and documentation under CSAR
• Local Chinese Responsible Person required
• Most imports still require animal testing unless exempt
• Dossiers submitted in the Chinese language

Japan – PMDA via MHLW

• Differentiate cosmetics vs quasi-drugs (medicated skin brighteners, etc.)
• All cosmetic products must comply with Japanese law and regulatory requirements to be sold in Japan
• No pre-market approval for cosmetics
• Labeling must include function + usage warnings per JP guidelines

UAE & GCC (GSO 1943/2016)

• Requires Arabic + English bilingual labelling for compliance across all GCC countries
• GCC regulations apply across multiple countries in the region, each with specific labelling and registration requirements
• All products need a Certificate of Free Sale (CFS)
• Local registration required with Dubai Municipality or SFDA
• Commonly banned: mercury, hydroquinone, steroids

Africa (e.g., Nigeria, South Africa, Kenya)

• Product notification or registration requirements vary across different countries in Africa, with each country having its own specific process.
• Various regulatory frameworks exist across the continent, so it is essential to carefully review the requirements for each market.
• Labels must list origin, full INCI names, and shelf life
• EU-format dossiers are often accepted with notarization
• Review local banned ingredient lists (mirroring EU Annex II)

Indonesia – BPOM

• Notification required before launch (all ingredients used in the product must be declared during the notification process)
• Must appoint a local distributor
• Halal labeling will become mandatory by 2026
• Labels must be in Bahasa Indonesia

Cosmetics Safety and Testing

Ensuring the safety of cosmetic products is a fundamental requirement for manufacturers and brands worldwide. Regulatory authorities mandate that every cosmetic undergoes thorough safety assessments, evaluating both individual ingredients and the finished product to identify any potential risks to consumers.

In the European Union, a comprehensive safety report is a mandatory component of the Product Information File (PIF), detailing the product’s composition, manufacturing process, and results from safety testing. The FDA also requires that cosmetic products marketed in the United States are safe for use, with manufacturers responsible for compliance with ingredient, labeling, and manufacturing regulations.

Safety testing can involve a range of methods, including in vitro assays, clinical evaluations, and, where permitted, animal testing. The primary goal of cosmetics safety testing is to ensure that products are safe for application on the human body, minimizing the risk of adverse reactions and supporting consumer confidence. Maintaining robust safety data and documentation is crucial for ensuring regulatory compliance and achieving market access.

Good Manufacturing Practices (GMP) in Cosmetic Product Manufacturing

Good Manufacturing Practices (GMP) are essential standards that underpin the quality and safety of cosmetic products across global markets. GMP guidelines set out the requirements for every stage of the manufacturing process, from raw material sourcing and production controls to quality assurance and labeling.

In the European Union, compliance with Good Manufacturing Practice (GMP) is mandatory for all cosmetic products, with manufacturers required to implement specific procedures for quality control and safety testing. The FDA also enforces Good Manufacturing Practice (GMP) requirements in the United States, including the registration of manufacturing facilities and the listing of cosmetic products.

Key aspects of Good Manufacturing Practice (GMP) in cosmetics include rigorous control of raw materials, standardized production processes, comprehensive quality checks, and accurate labeling. Adhering to GMP not only ensures the safety and consistency of cosmetic products but also helps companies avoid regulatory penalties, product recalls, and reputational damage. For manufacturers aiming to achieve and maintain compliance, following GMP guidelines is a non-negotiable part of operating in the cosmetics industry.

Responsible Person and Compliance: Global Requirements and Best Practices

The role of the Responsible Person is central to ensuring that cosmetic products meet the highest standards of safety, quality, and regulatory compliance across international markets. As global cosmetic regulations become increasingly stringent, appointing a Responsible Person is not just a legal requirement—it is a best practice for brands seeking to build consumer trust and maintain seamless market access.

European Union (EU)

Under the EU Cosmetics Regulation 1223/2009, every cosmetic product placed on the EU market must have a designated Responsible Person established within the European Union. This individual or entity is legally accountable for ensuring that the cosmetic product complies with all aspects of the regulation, including maintaining a comprehensive Product Information File (PIF), conducting a safety assessment, and ensuring that the product is manufactured according to Good Manufacturing Practices (GMP).

The Responsible Person must also verify that the labeling requirements are met, including a complete list of ingredients, usage instructions, and any necessary warnings. Additionally, the Responsible Person is responsible for product notification via the Cosmetic Product Notification Portal (CPNP) and for managing any post-market surveillance or adverse event reporting.

The United States

In the United States, the Responsible Person must ensure compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act, which regulates cosmetics to protect consumer health. This includes verifying that cosmetic products are safe for their intended use, that all ingredients are permitted and used within regulatory limits, and that labeling is accurate and not misleading.

The Responsible Person is also responsible for ensuring that the product is manufactured in accordance with GMP, that the facility is registered with the FDA, and that all required product and ingredient information is submitted through the appropriate digital platforms. Adverse event reporting and substantiation of product claims are also key responsibilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Japan

In Japan, the Responsible Person must comply with the Pharmaceutical and Medical Devices Law (PMDL), which governs the safety and labeling of cosmetic products. This includes ensuring that all ingredients are approved for use in cosmetics, that the product is manufactured under GMP, and that labeling meets Japanese regulatory standards. The Responsible Person is also tasked with maintaining up-to-date documentation and ensuring that the product remains compliant throughout its lifecycle.

Global Best Practices

Regardless of the market, the Responsible Person plays a pivotal role in ensuring that cosmetic products are safe, compliant, and ready for sale. Best practices for Responsible Persons include:

• Maintaining thorough and up-to-date documentation, including the Product Information File (PIF), safety assessments, and ingredient lists.
• Ensuring that all cosmetic products are manufactured in accordance with Good Manufacturing Practices (GMP) to guarantee consistent quality and safety.
• Verifying that labeling and packaging meet all local regulatory requirements, including language, list of ingredients, batch codes, and shelf life.
• Registering products with the relevant authorities in each country where the product is marketed, and keeping abreast of any regulatory changes.
• Conducting regular product testing and safety assessments to ensure ongoing compliance and consumer safety.
• Staying informed about evolving cosmetic regulations, such as updates to the EU Cosmetics Regulation, the FD&C Act, and other national laws.

By fulfilling these responsibilities, the Responsible Person ensures that cosmetic products are not only compliant with the law but also meet the expectations of consumers and regulatory authorities worldwide. This proactive approach to compliance helps brands avoid costly recalls, regulatory penalties, and reputational damage while supporting the safe and successful marketing of cosmetic products in the global marketplace.

Sustainability & Claims Compliance

As global consumers and regulators push for more transparency, sustainability-related claims are under increasing scrutiny. Ensure your brand's messaging aligns with the following:

• ISO 16128: Global standard defining natural and organic ingredient percentages
• EU Green Claims Directive: Avoid vague or unverifiable terms like “eco-friendly” or “non-toxic”
• Clean Beauty Claims: Avoid language such as “chemical-free,” “safe chemicals,” or “non-toxic” unless substantiated
• India (Draft Green Guidelines): Proposes third-party audits for eco-labeling (expected 2025+)

Recommended safe claims: “biodegradable formula,” “vegan-certified,” “formulated without parabens” (only if supported by documentation.

Digital Compliance & Registration Platforms

Each region requires product or ingredient registration via government-run digital systems:

Pro Tip: Always maintain backups of submitted documentation and verify approval timelines in each country. Managing time effectively is crucial—timely submissions help you meet registration deadlines, avoid delays in market access, and ensure ongoing compliance.

Private Label & OEM Compliance Responsibilities

For private labelers and contract manufacturers (OEM/ODM), regulatory roles must be clearly defined in agreements:

• In the EU: The brand owner or importer becomes the “Responsible Person” and must hold the PIF
• In India and UAE: Importers often take on legal responsibility; ensure the dossier matches the BIS/ESMA checklist
• In the US: Both OEM and brand must ensure MoCRA compliance (especially adverse event tracking)

Documents typically needed from your OEM/Formulator

• COA (Certificate of Analysis)
• MSDS (Material Safety Data Sheet)
• INCI-based formulation sheet
• Claim support file (efficacy or safety data)
• Safety assessment report
• Packaging compatibility data (for shelf life justification)

Labeling & Ingredient Checklist by Region

USA, EU, India, and China

Japan, UAE/GCC, Africa, and Indonesia

Global Strategy Tips for B2B Cosmetic Brands

• Utilize INCI-listed and REACH-pre-approved ingredients, using only those that are pre-approved in all target markets, to minimize regulatory hurdles
• Choose filters and preservatives that are approved in all markets (e.g., zinc oxide)
• Work with suppliers who provide COA, MSDS, toxicological data, and usage justifications
• Align claims with the most conservative market (usually the EU).
• Ensure stability, micro, and packaging compatibility tests are included in the PIF or export file, and understand international regulations well to ensure compliance

Final Word: Compliance is a Scalable Strategy

Cosmetic regulation may seem complex, but global success depends on documentation, ingredient transparency, and country-by-country customization. The more proactively you align your ingredient sourcing and labeling with MoCRA, REACH, BIS, and other emerging regulations, the more efficiently you scale into new markets.