BioScreen Testing conducts both the official QVC QA regulatory review for compliance with QVC Protocol, as well as the Microbiology, Chemistry and Clinical tests required for the Dossier Review.
QVC Product Protocol Dossier Evaluation
For QVC QA regulatory review, BioScreen will conduct: cosmetic label review, Dossier folder review of testing performed and tests for defects, workmanship and dispense function where applicable.
Dossier Order List: (Some items may not be applicable for your product type being reviewed.)
- QVC Product Sample Submission Form
- OTC Product- SPF-Sunscreen Drug Product testing documentation
- OTC Product- SPF-Sunscreen Active ingredient(s) testing documentation
- Preservative Effectiveness Test per USP <51> as applicable- not for anhydrous products
- Sterilization Certificate (as applicable for products containing natural hair)
- Repeat Insult Patch Test (RIPT) or 48 Hour Patch Test depending on product type
- Toxicological risk Assessment (where applicable)
- Flash Point (only as applicable)
- Flammability (only as applicable)
- Freeze/Thaw Stability- not applicable for anhydrous products
- Elevated Temperature Stability
QVC Product Protocol Required Testing for Dossier Evaluation
The following tests are required by QVC per their protocol which is spelled out in the test descriptions. Some tests may not be applicable for your product and, therefore, are not required.
A. Prop 65 Testing: (Detection limit is parts per million) Recommended but not required.
For Make-up products:
Heavy Metals by ICP-MS (Lead, Arsenic, & Cadmium)
For products that are in plastic containers: (Recommended but not required)
Scope: Perform extraction for phthaltes from cosmetic product using methanol, hexane or methylene chloride and sonication followed by GCMS analysis of the extract for the following phthalates.
B. OTC Products- SPF Determination- Sunscreen Drug Products
C. OTC Products – Sunscreen Drug Products SPF Active Ingredients
D. Preservative Effectiveness (As applicable- not required for anhydrous products)
Growth of microorganisms introduced into the product by the consumer, or by growth of organisms originally in the product, can threaten the health of the consumer. All cosmetics, particularly those cosmetics applied on or around the orbital (eye) area, must be adequately preserved to minimize this health threat. The U.S. Pharmacopoeia Anti-Microbial Preservative Effectiveness Study, or a substantially similar protocol, must be used.
F. Repeat Insult Patch Test/ 48 Hour Patch Test
A Repeated Insult Patch Test determines if a product may be sensitizing or irritating to the skin of the user. A qualified laboratory must conduct the study and the sponsor should specify the use of a semi-occlusive patch for the testing, since occlusive patches will often exhibit false positive readings.
*The Repeat Insult Patch Test is required for all leave on products.
** Human Primary Irritation Test (48 hour Patch) is required for all rinse-off/products that are not in direct contact with the skin
G. 16 CFR 1500.3- Toxicological Risk Assessment (As applicable)
A TRA is required for products that cannot be tested via a RIPT or 48 hour patch test. A TRA is not required for products in which a RIPT has already been completed. QVC requires a TRA for mouth rinse, toothpaste, teeth whitening products and nail polish.
H. Flash Point (As applicable)
I. Flammability (As applicable)
*These tests will be outsourced to one of BioScreen’s approved laboratories.
J. Freeze-Thaw Stability
Testing that determines the low temperature stability of a product and that adequate packaging headspace has been afforded (if applicable to the product). The general procedure includes exposure to -10 to -150F temperatures for twelve hours followed by a twelve-hour thawing period at ambient temperature (720F). This cycling should be repeated two more times for a total of three cycles. The testing must be performed with packaging, fill volume and closure torque specification that is representative of that which will be used during the filling operation.
After the third cycle is complete, the product is compared to samples that have not undergone freeze/thaw testing and examined for any chemical or physical changes such as emulsion breakage/separation and/or viscosity changes, etc. Additionally, if container breakage occurs, head spacing or product formulation should be modified and the test repeated.
K. ELEVATED TEMPERATURE STABILITY
Testing that determines the elevated temperature stability of a product and that adequate packaging headspace has been afforded (if applicable to the product). The general procedure includes exposure to 1150F temperatures for 72 hours followed by examination of the product. The testing must be performed with packaging, fill volume and closure torque specification that is representative of that which will be used during the filling operation.
After 72 hours the product is compared to samples that have not undergone elevated temperature testing and examined for any physical, chemical or microbiological changes. Additionally, if container breakage occurs, head spacing or product formulation should be modified and the test repeated.
Storage of cosmetic products at elevated temperatures will also provide an accelerated shelf-life profile for the product, usually showing quickly the reactions that may occur over the next 6 or 9 months. Such reactions could be emulsion breakage, separation, precipitation, microbial growth, color or odor changes, viscosity changes, and other product modifications that would occur over time or upon exposure to high temperatures.
L. EFFICACY CLAIMS SUBSTANTIATION/CLINICAL TRIALS
Cosmetics that claim a specific benefit or effect, aside from those claims generally understood to be true, must be tested for efficacy. Efficacy testing should be conducted by a credible laboratory that is qualified to interpret data and reactions resulting from the use of the cosmetic. Please refer to the QVC Claims Substantiation Guidelines for more information on efficacy testing. BioScreen Clinical Services will be happy to assist you in developing the scope, protocol and performing the clinical trial. Please contact our Client Services Department for details.