Ensure Your Cosmetic Products Are Safe and Compliant with QSS

Substantiate the safety of all your cosmetic products and ensure that all your ingredients are safe and compliant with industry standards. With QSS Cosmetic Safety Substantiation solutions, you can demonstrate adequate substantiation of the safety of your cosmetic product by way of evidence provided by research, analyses, or other scientific evidence.

We help manufacturers or the responsible Person for a cosmetic product gather all the safety data related to cosmetic product ingredients from various robust sources such as valid scientific data and prepare a comprehensive report.

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What is cosmetic safety substantiation?

Cosmetic Safety Substantiation is the process of ensuring that a cosmetic product is safe for use by consumers. Section 608 of MoCRA outlines the FDA’s requirements for safety substantiation. According to it, the companies or responsible person for a cosmetic product must maintain records supporting adequate safety substantiation for their cosmetic products.

Is safety substantiation mandatory?

Yes, cosmetic Safety Substantiation is mandatory. MoCRA requires all cosmetic products to undergo safety substantiation before being available for public use. This means manufacturers (or whoever’s responsible for the product) need to have documented proof that their cosmetics have been thoroughly tested and are safe for consumers.

Compliance with these regulations is essential to avoid legal issues, protect consumer safety, and uphold brand integrity. MoCRA defines “adequate substantiation” as any combination of tests, studies, research, or data analysis that a qualified scientific expert would consider sufficient to demonstrate, with a reasonable degree of certainty, that the cosmetic product is safe for use.

How is safety substantiation done?

There isn’t a single prescribed method for safety substantiation. The approach varies based on factors such as the product’s ingredients, intended use, and potential risks. Common methods include:

Formulation analysis and safety testing
Conducting toxicological risk assessments
Reviewing the safety profile of individual ingredients
Performing in-vitro (laboratory) testing
Commissioning clinical trials

Who is responsible for safety substantiation?

Cosmetic product manufacturers, importers, or distributors are responsible for safety substantiation. They must ensure they have proper documentation to ensure the safety of their products.

Manufacturer: The entity that formulates, produces, or packages the cosmetic product.
Importer: If the cosmetic product is imported from another country, the importer may be designated as the person responsible.
Distributor: In some cases, the distributor or marketer of the cosmetic product may be responsible for safety substantiation.

How Quality Smart Solutions Assists in Safety Substantiation

Quality Smart Solutions provides comprehensive services that ensure your cosmetics meet all regulatory standards, giving you peace of mind and keeping your customers safe. Here’s how we help:

Evaluate overall formulation for ingredient stability, compatibility and interaction.
Assess individual ingredient safety through toxicity and adverse effects studies.
Identify potential hazards considering exposure levels, usage frequency.
Compile data, test results, and assessments into a comprehensive report.
Align with FDA regulations to get approvals for marketing.
Monitor product safety post-launch through surveillance and adverse event reporting.

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About us

Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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