The New FDA monograph that has yet to be put into effect requires that testing take place on 20 human subjects in an FDA approved laboratory. This replaces the requirement for five human subjects. We have decided to do all our testing on 20 subjects. This includes:
- Amazing Base
- PurePressed Base
- Dream Tint
- Lip Drink
The SPF on the carton is the average measurement taken from the results of the 20 subjects.
We are now in the process of testing our products for their UVA rating. The FDA has yet to confirm the methodology. However, it is rumored that they are about to confirm the Japanese protocol and so we have already tested Dream Tint under this methodology. It received an eight which puts it in the High ranking.
This is an in vitro test conducted with light rays to determine the percentage of active ingredients. It is required by some countries in order to register products claiming an SPF. The light rays measure the absorption and reflection of light in order to confirm the percentage of actives, in our case titanium dioxide and zinc oxide. It is an uncertain test but an interesting one. For example, the analysis of the test we just conducted on Warm Silk indicated an SPF 37.
This measures shelf life. The product can be tested in real time, provided the product has been in the line long enough, or it can be measured through an incubation process. This subjects the product to intense heat and cold for a period of one month. This acceleration is equal to one year. All of our products have undergone this test and where possible, the real time test.
PAO (Period After Opening)
It is now a requirement of the EU that all boxes and labels contain the symbol of an open jar with the number of months the consumer can expect to use the product at its optimal performance. This is a subjective test with no defining rules. However, the object is to be able to convince regulatory authorities that the manufacturer can back-up the period it advertises.
We sent to the laboratory powder bases that we have had in our makeup room for four years or longer and that have been used periodically during that time. We tested five pressed powders and three loose powders. In every case, there were no microorganisms. We could back up a 48 month PAO, but have decided to print 24M (24 months) on the box. We have been advised to choose a lesser time so that it doesn’t appear out of place to the customs authorities. All other products, except D20, Balance and POMMISSThave a PAO of 12 months.
We firmly believe that all our mineral powders have an indefinite PAO.
BEST USED BY
We are printing a “Best used by…” date on D20, Balance and POMMISST.Date will be one year from filling. This doesn’t mean that the product is harmful after that date but that it is optimum during the first year. If any change is discernible, it would be in the lessening of the fragrance.
REPEAT INSULT PATCH TEST
This is a sensitivity test conducted on 50 people per product. This is two-phase test which tests irritancy and sensitivity. During the first phase, the test is repeated three times on the same subject within a week. There is a ten to fourteen day break and then the subject is patch-tested for three consecutive days. There is a 24-hour evaluation and 48-hour evaluation. In every case, the results of being tested with our products were negative. No sensitivity recorded to any product. The legitimate claims we can now make are:
PET (CHALLENGE TEST)
This test proves the efficacy of the preservative system. We were particularly interested in the results because of our insistence on using systems that don’t rely on parabens and phenoxyethanol but rely on more natural methods. In a laboratory, bacteria, yeast and mold were introduced into the product:
- Staphylococcus aureus
- Staphylococcus epidermidis
- Pseudomoas aeruginosa
- Pseudomonas putida
- Escerichia coli
- Enterobacter aerogenes
- Proteus vulgaris
- Serratia marcescens
- Saccharomices cerevistae
- Candida albicans
- Aspergillus niger
- Aspergillus flavus
- Pennicillium notatum
Staphylococcus epidermidis, Pseudomoas aeruginosa and Escerichia coli
(E. coli) were introduced a second and third time after allowing seven days of incubation. The test allows the evaluation of the real capacity of the preservative system of not only preventing microbial contamination but of also reducing it to a level that is safe for human health. In other words, the preservative system has to be able to kill the organisms.
When the test was finished (21 days) no microbial activity was detectible.
We have completed comedogenicity tests on all products. All products showed no comedogenicity.
We have conducted heavy metal tests on all products. There is no measurable amount of heavy metals in any product including lead and nickel.
IMC has conducted tests not required of it as a cosmetic manufacturer, but it has done so because it believes in offering you the highest quality product line possible.