Global Cosmetic Safety Assessment Regulations and Solutions
At REACH24H, we offer comprehensive safety assessment services tailored to meet global regulatory requirements, ensuring your cosmetic products are safe, compliant, and ready for market entry, including China, the ASEAN region, the United States, and the European Union.
Ensuring the safety of cosmetic products is paramount due to their everyday use by consumers worldwide. Regulatory authorities across various countries mandate that cosmetic products be thoroughly assessed for safety to protect consumer health. However, challenges such as complex formulations, stability of the products, microbial contamination, novel ingredients, regional regulatory differences, and individual sensitivities and allergies make safety assessments a demanding yet essential task.
Adding to these challenges, the scientific understanding of chemical substances continues to evolve. Identifying potential hazards associated with certain ingredients may take time, underscoring the need for ongoing vigilance and expertise in safety evaluations.
China: CSAR and Technical Guidelines
China’s regulatory landscape is governed by the Cosmetic Supervision and Administration Regulation (CSAR) and supporting technical guidelines – Technical Guidelines for Cosmetics Safety Assessment (2021 Edition). Key requirements include:
- Mandatory Comprehensive Reports: Starting May 1, 2025, all cosmetics submitted for notification or registration must include a comprehensive safety assessment report. Until then, simplified safety assessment reports will be accepted.
- Qualified Assessors: Safety assessments must be performed by qualified professionals with documented expertise in cosmetics safety. The safety assessment report must include the assessor’s credentials, such as educational background, relevant work experience, and professional training history.
| Safety Assessment Report of Cosmetic Products |
|
To know your ingredient regulatory status, try our COSMETIC INGREDIENT SEARCH TOOL for a comprehensive search.
ASEAN: Unified Framework Under the ACD
The ASEAN Cosmetic Directive (ACD) establishes a unified framework for the 11 ASEAN member states* to ensure the safety and compliance of cosmetic products. It sets guidelines for prohibited, restricted, and permitted ingredients, manufacturing practices, safety assessments, efficacy claims, and product labeling.
(*Member states include Brunei, Cambodia, Indonesia, Malaysia, Myanmar, Laos, Philippines, Singapore, Thailand, Vietnam, and Timor-Leste.)
While the ACD provides overarching regional guidelines, individual member states may enforce additional requirements, making localized expertise crucial for compliance. Common safety assessment elements include evaluating product ingredients, conducting local tolerance testing, and ensuring microbiological quality and stability.
However, the specific safety assessment requirements can vary by country, as they are influenced by national regulations. Assessments must be carried out by qualified professionals, referred to as “Safety Assessors.”
United States: MoCRA and State-Level Regulations
The Modernization of Cosmetics Regulation Act (MoCRA), effective in December 2022, introduced requirements for the safety substantiation of cosmetic products.
Unlike some countries with detailed cosmetic safety assessment guidelines, the United States, under the Federal Food, Drug, and Cosmetic Act (FDCA), lacks specific directives for conducting safety assessments. While animal testing is not required for marketing cosmetics under MoCRA, the FDA emphasizes that all safety data must be derived from scientifically robust methods.
As the FDA has not provided detailed safety assessment requirements, REACH24H recommends two approaches to meet MoCRA’s safety substantiation requirements:
- Leverage Existing International Safety Assessments: Use safety assessment reports prepared according to established technical guidelines, such as the EU’s Cosmetic Product Safety Report (CPSR) or China’s comprehensive safety assessment.
- Provide a Toxicological Risk Assessment (TRA): Submit a TRA report that aligns with the Cosmetic, Toiletry, and Fragrance Association (CTFA) Safety Evaluation Guidelines in the United States.
Both approaches ensure alignment with MoCRA while addressing federal and state-specific requirements.
It is essential to recognize that numerous U.S. state regulations, such as California Proposition 65, impose distinct requirements for banned substances in cosmetics. As a result, companies need to address both federal safety substantiation standards and state-specific ingredient restrictions.
European Union (EU): CPSR and Safety Standards
The EU enforces strict safety assessment requirements under Regulation (EC) No. 1223/2009, ensuring cosmetics are safe before they reach the market. Key highlights include:
- Cosmetic Product Safety Report (CPSR): A mandatory component of the Product Information File (PIF), detailing the safety of ingredients, finished product stability, manufacturing processes, and microbiological quality.
- Qualified Safety Assessors: Safety assessors are critical in ensuring compliance with EU safety standards. They must hold recognized qualifications in toxicology, pharmacy, medicine, or related disciplines. These qualifications must be formally certified through a university course or an equivalent program recognized by an EU member state. Documentation proving the assessor’s qualifications must also be included in the CPSR. Regulations require assessors to review all safety-related data comprehensively and provide a conclusion on the product’s safety.
| Cosmetic Product Safety Report (CPSR) | |
| Part A: Cosmetic Product Safety Information | Part B: Cosmetic Product Safety Assessment |
| · Quantitative and Qualitative composition of the product
· Physical/chemical characteristics and stability of the cosmetic product · Microbiological quality · Impurities, traces, information about the packaging material · Normal and reasonably foreseeable use Exposure to the cosmetic product · Exposure to the substance · Toxicological profile of the substance · Undesirable effects and serious undesirable effects · Information on the cosmetic product |
· Assessment conclusion
· Labeled warnings and instructions for use · Reasoning · Assessor’s credentials and approval of part B
|
How REACH24H Can Help with Cosmetic Safety Assessment
At REACH24H Consulting Group, we understand the complexities that cosmetics companies face when addressing safety assessment requirements across multiple countries. From reviewing formulations for ingredient compliance to providing diverse assessment approaches by qualified safety assessors, we are here to help.
- Comprehensive Services for Safety Assessment: We are well-versed in the cosmetic regulatory requirements of key markets, including regulatory updates monitoring, ingredient management status, animal testing policies, and supervision practices. Our expertise ensures that your products comply with the safety assessment criteria of various countries, facilitating a smooth entry into your target markets.
- Proprietary Safety Databases: We utilize in-house databases for ingredient safety, regulatory updates, and compliance insights, ensuring accuracy and efficiency.
- Qualified Safety Assessors: Our team includes certified toxicologists recognized by leading regulatory bodies in the US, EU, and China, offering unmatched expertise for your products.
- Confidentiality and Data Security: We adhere to strict confidentiality protocols, safeguarding your business-critical information at all times.
Why Choose REACH24H for Your Cosmetic Regulatory Needs
With years of experience supporting over 1,000 global cosmetic companies, REACH24H delivers effective regulatory solutions tailored to Indonesia’s cosmetic market. Backed by a global presence with 8 offices worldwide and a network of local regulatory specialists, our team ensures your products comply with safety assessment requirements and are market-ready without unnecessary delays.
For more information, contact us at customer@reach24h.com.
