Are you looking to determine the safety and efficacy of a new cosmetic, sunscreen or hair care product? Whether you need product quality tests, in vitro toxicity analysis, or evidence to support claims, we can help. 

Mérieux NutriSciences offers expert clinical tests and analytical services to support the development of new personal care and cosmetic products.
Our studies are conducted according to international guidelines and protocols in compliance with top-level quality standards (GLP/GMP, ISO 17025).
Our services include:

  • Efficacy and claims support
  • Safety
  • Physico-chemical quality control
  • Microbiological quality control
  • Stability and period after opening (PAO)
  • Sensory analysis and consumer research

Mérieux NutriSciences Italy supports us to meet your requirements on Personal Care and Cosmetics services. For further information, please fill up our contact form.

All our Tests and Services

OTC (over-the-counter) medicines are safe and effective drugs used by the general public without prior recourse to a healthcare professional. 

Similarly, cosmetic products can be considered as OTCs. Some products meet the definitions of both cosmetics and drugs. Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic. Likewise, certain active ingredients can cause a product to be considered a drug owing to their therapeutic use.

OTC products compliant with the OTC drug monograph may be marketed without prior FDA approval.

For example, in the U.S., antidandruff shampoos and sunscreen products (link to sunscreen products) are considered to be OTCs.

OTCs must be manufactured and controlled in accordance with cGMP requirements for pharmaceuticals for human consumption.

Mérieux NutriSciences can help with cGMP compliance in relation to the following:

  • Method development and validation
  • Quality control
  • Stability testing

Mérieux NutriSciences can work with your R&D and marketing teams to perform clinical evaluations in order to demonstrate the efficacy of your product. Our full-service offer includes study design and consultancy on protocols to support specific claims and label information, along with data monitoring and biostatistical expertise.

Our scientific evaluations on human volunteers provide essential data to substantiate claims such as wrinkle reduction, water resistance and sun protection factors.

The laboratory offers a high level of performance and flexibility to address a wide range of studies.

It is possible to provide evidence of cosmetic product efficacy using an integrated approach offering synergy between various skin imaging techniques.

All clinical tests are conducted in accordance with international regulatory guidelines and in full compliance with the ethical principles set out in the Declaration of Helsinki. They are carried out by qualified and suitably trained technicians.

Mérieux NutriSciences offers in vivo testing on healthy volunteers to provide scientific data in support of the following claims:

  • Facial care
  • Body care
  • Hair care
  • Make-up
  • Toiletries
  • Sunscreen products
  • Nail care
  • Oral care
  • Microbiota analysis

Mérieux NutriSciences offers a full range of scientific tests to support your safety evaluations.

We use both in vitro toxicity tests and in vivo clinical tests to gather essential data as part of an integrated testing strategy (ITS) for safety evaluation.

  • In vivo testing
  • In vitro testing

Our ISO-accredited labs perform a wide range of chemical and physical analyses of cosmetic products in accordance with ICH guidelines. We use instrumental techniques including HS GC-MS/FID, HLPC-DAD, LC-MS and ICP-AES.

We perform the following quality controls and analyses to verify that all of your products’ features are compliant with label definitions and are maintained throughout the shelf life:

  • Quantification of active ingredients, such as:
    • UV filters
    • Preservatives
    • Anti-dandruff components
    • Hair conditioners
    • Humectants, etc.
  • Determination of prohibited and restricted substances, such as:
    • Metals (Ni, Cr, Cd, Hg, Pb, As, Sb and others)
    • Formaldehyde
    • NDELA
    • Dioxane
    • PAHs
    • Phthalates
    • Allergenic fragrance substances
    • Other restricted substances
  • Raw material characterization
  • Analysis of volatile compounds in flavorings, fragrances and essential oils
  • Off-flavors analysis
  • Specific tests on demand

Validation of cleaning processes/procedures

As a manufacturer, you need to ensure your product's purity and quality for its intended use by consumers. Our microbiological cosmetic testing labs can help.

Mérieux NutriSciences performs characterization and quantification of microorganisms in final cosmetic and personal care products, in intermediate products and for the control of manufacturing environments. We conduct tests to assess the efficiency of antimicrobial preservation agents, as well as sterility and bioburden tests.

Our protocols follow ISO methods and the official recommendations of all major international regulatory bodies.

Our range of microbiological analyses includes:

  • Challenge tests
  • Evaluation of microbial activity or ‘in use’ tests
  • Evaluation of formula stability and/or determination of the period after opening (PAO)
  • Microbiological analyses and determination of aerobic mesophile bacteria, mycetes and pathogens:
    • Staphylococcus aureus
    • Pseudomonas aeruginosa
    • Candida albicans
    • Escherichia coli (E. coli)
  • Microorganism isolation, identification (sequencing & MALDI-TOF) and storage
  • Validation of cleaning processes/procedures

To ensure that your products meet quality standards when stored under proper conditions, a safety and stability assessment is required. Mérieux NutriSciences provides a full complement of customizable analytical methods in order to respond to customer requirements on a case-by-case basis.

Cosmetic and personal care products are made using a wide variety of materials and formulations, making it impossible to establish a standard protocol applicable to all. Regulators recommend that stability tests be adapted according to the type of product and intended use, including reasonably foreseeable storage conditions.

Our stability assessments cover the following parameters and are based on international guidelines:

  • Organoleptic and sensory properties: appearance, color, odor and flavor, as applicable
  • Physical-chemical properties: pH value, viscosity, density and, if necessary, ingredient formulation
  • Microbiological properties: microbial count and preservation challenge test
  • Monitoring of active substances: UV filters, antioxidants, antimicrobial agents, etc.
  • Screening of aromatic substances to determinate qualitative and quantitative fragrance alteration

Accelerated stability, also known as normal or exploratory stability, can help to predict a product’s stability and useful shelf life, as well as the compatibility of the formulation with the materials with which it will enter into contact.

Other specific storage conditions that can be applied are:

  • Period after opening (PAO): simulation of useful lifespan
  • Thermal shock, with protocols that provide alternate cycles at different temperatures
  • Light stability (Xenon test) of finished products
  • Photostability of chemical UV filters

Content to be provided by Biofortis

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