PIF (Product Information File) & CPSR (Cosmetic Product Safety Report)

   

Global Regulatory Affairs Consulting Agency, KGMP CORP.

 

Cosmetic PIF (Product Information File) and

CPSR (Cosmetic Product Safety Report) 

 

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

As a leader in cosmetic and personal care consulting, KGMP provides expert guidance to help you navigate market-specific regulations, ensuring your products meet local standards for safe export and distribution. Partner with us to ensure your products are safe, effective, and compliant with both local and global regulations.

Cosmetic PIF and CPSR Compliance: Essential Insights for Your Business

The Cosmetic Product Information File (PIF) and Cosmetic Product Safety Report (CPSR) are essential for compliance with regulatory standards, especially within the EU and ASEAN.

Each cosmetic product is required to have its own PIF, containing essential information such as the CPSR, product description, manufacturing methods, and more, making it accessible for regulatory inspection. When a cosmetic product is marketed in countries requiring a PIF, the Responsible Person (RP) must maintain and keep it for at least 10 years from the date the last batch was distributed, with any product updates promptly reflected in the PIF.

KGMP provides this framework to assist clients in navigating regulatory compliance and ensuring product safety.

 

KGMP Cosmetic PIF & CPSR Service

Ingredients & Product data review	Product safety assessment	Additional safety test	PIF & CPSR documentation

Key Stage of PIF and CPSR Documentation

The Product Information File (PIF), Cosmetic Product Safety Report (CPSR), and Safety Assessment are often used interchangeably or misinterpreted, resulting in misunderstandings and compliance issues. While these documents are closely related and support manufacturers in meeting regulatory requirements and mitigating risks, each serves a distinct purpose under cosmetic regulations, making accurate compilation essential.

Our specialists handle PIF and CPSR documentation using extensive regulatory guidance from relevant authorities in your target country to ensure compliance. With our expert evaluations, you can navigate global expansion more smoothly, ensuring your products meet top standards. Our specialists in global regulations allow us to consolidate country-specific requirements into a single, efficient document, streamlining your compliance process.

Cosmetic PIF (Product Information File) Includes:

A PIF is a comprehensive dossier that provides extensive information about a cosmetic product, encompassing its formulation, packaging, and safety assessments.

ㆍ      Description of the cosmetic product

ㆍ      Manufacturing process

ㆍ      The Cosmetic Product Safety Report (CPSR)

ㆍ      Evidence of the claimed effect on the cosmetic product

ㆍ      Data on any animal testing

 

Cosmetic CPSR (Cosmetic Product Safety Report) Includes:

The CPSR, an essential component of the PIF, provides a health risk evaluation conducted by qualified experts to ensure product safety before market entry. It is divided into two sections.

Part A. Cosmetic Product Safety Information

ㆍ      Quantitative and qualitative formula of the cosmetic product

ㆍ      Physicochemical characteristics and stability of the cosmetic product

ㆍ      Microbiological quality

ㆍ      Impurities, traces, information about the packaging material

ㆍ      Normal and reasonably foreseeable use

Part B. Cosmetic Product Safety Assessment

ㆍ      Conclusion of the evaluation

ㆍ      Warning and instructions for use on the label

ㆍ      Reasoning

ㆍ      References of the assessor and approval of Part B

 

Cosmetic Product Safety Assessment

The Cosmetic Product Safety Assessment on CPSR provides an expert opinion on the product's safety for market placement. It shall be carried out by “a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent,” also known as the Safety Assessor, such as KGMP.

Remember that different regulations apply in each country.

Contact us today to discover how our product ingredient and label compliance services can benefit your business.

KGMP simplifies compliance with complex cosmetic regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.     

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

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