Hampton, Virginia, March 08, 2023 (GLOBE NEWSWIRE) -- Leading FDA service, software, and training firm, Registrar Corp, recently announced the release of a Cosmetic Product Safety Report (CPSR) feature within Cosmetri, Registrar Corp’s comprehensive regulatory and formulation software for cosmetics businesses.
This tool, within Cosmetri’s Product Manager application, fully integrates cosmetic Product Information Files (PIFs) into the software, further supporting customer efforts to meet regulatory requirements for documentation. Previously, firms needed to upload external CPSRs into Cosmetri manually. This new feature alleviates the need for time-consuming data entry by automating PIF generation and streamlining the safety assessment process.
How Does Cosmetri Help with CPSRs?
Cosmetri now automatically generates a complete PIF using cosmetics formulations already in the software. The CPSR feature also enables Safety Assessors to log in to the system, complete parts A and B of the CPSR section within the PIF and sign off on the CPSR upon completion.
“The CPSR feature creates a streamlined process for companies and safety assessors to complete and manage safety data,” said Jaclyn Bellomo, Registrar Corp’s Director of Cosmetics Services and Software. “With this feature, a Safety Assessor can enter all tests, calculations, and analysis of the ingredients in a final cosmetic product. Companies can view and manage this data and verify that the cosmetic product is safe based on the assessment.”
By bringing all the CPSR elements onto one convenient platform, users can spend more time actively engaged in risk assessments and collaborating directly with product integrity teams rather than managing tedious paperwork.
Bellomo goes on to say, “With many regulations changing to place safety and transparency at the forefront, and with countries requiring this assessment to market a cosmetic product, the CPSR feature helps companies meet these requirements efficiently.”
What is a PIF?
A PIF is comprised of supporting documentation that describes and demonstrates the safety of a cosmetic product. The PIF must contain:
- A detailed product description that attributes the PIF to the product
- The CPSR (see below)
- A description of the manufacturing process and a statement of adherence to GMPs
- Proof that the product functions as claimed
- Animal testing data
Companies must keep PIFs for 10 years after the product’s last batch was placed on the market.
What is a CPSR?
A CPSR is one of the key elements of a PIF. Cosmetics companies must perform a safety assessment that meets certain regulations before marketing their products in the EU, UK (Regulation (EC) No. 1223/2009), and in the Association of Southeast Asian Nations (ASEAN) region (ACD section 2.2). CPSRs includes details about the product’s safety assessment.
A CPSR is comprised of two parts:
- Part A: Cosmetic Product Safety Information – a collection of data that demonstrates the safety of the cosmetic product
- Part B: Cosmetic Product Safety Assessment – based on part A, an evaluation of the cosmetic product’s safety, including references from a Safety Assessor and the Safety Assessor's education and credentials (uploaded by the administrative user)
Cosmetri Director Matthias Raetz said, "Safety Assessors who utilize Cosmetri's CPSR functionality are able to do their job more completely, accurately, and quickly, while also ensuring sensitive information within their CPSRs remain confidential and secure."
Registrar Corp’s Additional Compliance Solutions
Registrar Corp provides FDA compliance services for food, medical device, drug, and cosmetics establishments. Along with cosmetics software, the company also assists with the following:
- FDA registration and renewal
- Detentions
- Inspection preparation
- Food safety regulations
- Software solutions for compliance
About Registrar Corp
Registrar Corp is the leading provider of FDA services, software, and training. Since opening its Hampton, Virginia headquarters in 2003, Registrar Corp has expanded to 20 worldwide offices and has aided more than 50,000 companies across 160 countries.
If you have questions about cosmetics requirements or Registrar Corp’s software solutions, contact Registrar Corp at info@registrarcorp.com or call +1-757-224-0177 (option 5).
