The field of skin care products, including that of natural cosmetics, is subject to several regulations that you are required to follow -as manufacturers- in order to ensure the health and safety of your customers. Regulatory testing is an integral part of it, here’s everything you need to know in this article:
Cosmetic evaluation, why and how?
Your company must be able to comply with the recommendations of international regulatory bodies, and to confirm that your natural cosmetic products intended to be placed on the market do not compromise human health. For this, it is necessary to conduct a safety assessment of the products when they are applied under normal and reasonably foreseeable conditions of use.
This cosmetic evaluation must be mentioned in the dossier of each product, and can be based on knowledge of the toxicity of the ingredients as well as on tests carried out on the final product. This is particularly relevant if the interaction between the ingredients is likely to cause the formation of a new potentially toxic or irritant substance, if there is a specific safety claim, if significant changes in the formula have been made, or if a new ingredient known to cause mild eye or skin irritation is present.
What are the regulatory tests to be performed on a cosmetic product? There are three broad categories of tests: stability and conversion tests (a), safety tests (b), and product efficacy tests (c).
Stability and conservation tests
In order to assess the good performance and good protection over time of the cosmetic product, the following tests must be carried out:
The stability test: Stability studies consist in subjecting the product to accelerated aging and estimating its integrity during storage or after transport (truck, plane, boat). The product will be placed in an oven at a specific temperature for several months. During this period, samples will be taken in order to control the quality of the product in its final packaging.
The challenge test: This test allows the performance of the preservative system to be evaluated before the finished product is marketed. It consists of inoculating a known concentration of specific germs in the product. A criterion is determined based on the rate of population decline over a period of 28 days. In some cases (extreme pH, high percentage of ethyl alcohol, etc.), the challenge test is not necessary or relevant to assess the resistance of the product to contamination. Physico-chemical tests make it possible to justify the low risk of contamination of the finished product.
Safety tests
In order to determine whether the cosmetic product will not cause undesirable effects during its application, the following tests must be carried out:
The ocular tolerance test: If the product is intended to be applied to the eye area or if its reasonably foreseeable use induces possible contact with the eye area (facial cleanser, shampoo etc.) it is necessary to prove the absence of risk to the eyes of the consumer by an eye irritation test, the most common being the Het-Cam test. These in-vitro tests can give valuable clues as to the safety of the finished product before considering skin irritation tests on a human panel called a patch test.
The patch test or the skin tolerance test: This is an ex vivo skin tolerance test on the human skin of the back which consists of applying a product under an occlusive or semi-occlusive patch. The patch is applied for 24 to 48 hours. Upon removal of the patch, any reactions are observed and noted. To obtain more information concerning the tolerance of the product, it is possible to carry out further investigations by carrying out other tests (phototoxicity tests, use test, open test by repeated application or ROAT, sensitization test or HRIPT, etc. .).
Product efficacy tests
In order to prove the effectiveness of a cosmetic product, it is necessary to perform the following tests (on a voluntary panel or by in vitro tests for a particular claim (nourishing, radiance, cell renewal, anti wrinkle, firming, slimming…)):
The patch test or the skin tolerance test: This is an ex vivo skin tolerance test on the human skin of the back which consists of applying a product under an occlusive or semi-occlusive dressing. The patch is applied for 24 to 48 hours. Upon removal of the dressing, any reactions are observed and noted. To obtain more information concerning the tolerance of the product, it is possible to carry out further investigations by carrying out other tests (phototoxicity tests, use test, open test by repeated application or ROAT, sensitization test or HRIPT, etc. .).
Clinical or instrumental tests: The product is given to the laboratory which applies it to the subjects at a determined frequency. The results are taken from instrumental measurements with the aim of obtaining an average over the entire panel (2.6 cm less waist circumference, wrinkle depth reduced by 50%, etc.).
Results: Once proof of safety and efficacy is provided, the cosmetic dossier can be finalized. The cosmetic product is therefore ready for its registration and notification to the competent authorities (in France: CPNP (European portal for the notification of cosmetic products)), before it is placed on the market.
If all these regulations to follow seem intimidating to you, do not panic, Prodigia is there to advise you and accompany you along the way. We can supply you in bulk, offer you natural cosmetics products in white label, offer you legal support in the creation of your brand, and even international shipment.
