Inside Cosmeceuticals conducted a Q&A with Alion Science and Technology's bioassay solutions program manager, John D. Gordon, Ph.D., on the current need, process and advantages of testing for harmful substances, including endocrine disruptors, in personal care/cosmetic formulations/products.
IC: With many companies making more sustainable efforts to avoid harmful substances in cosmeceutical formulations, what steps can be taken to avoid their inclusion?
Gordon: The only real way to ensure that a particular harmful substance or toxin is not included in the formulation of a product is through testing. Contamination can come from a wide variety of sources such as: a supplier unknowingly caused contamination; over oiling a grinder; a contaminated container; etc. The best way is to test the finished product. This will allow for the entire process to be tested just prior to consumption. Another way would be to test all ingredients from suppliers prior to final production, but you could still get contamination in the final assembly of the product or from the container the product is shipped in.
There are several new in vitro bioassays that allow for toxicity testing without the use of animal testing, which is very popular among cosmetic consumers.
To ensure that a product is free of detectable levels of harmful substances, each lot of a product line must be tested. No agency accepts “skip lot" or yearly testing for toxic substances. Toxicity testing differs from nutritional testing in that if you are off by a few nanograms of vitamin C in a 1,000-mg vitamin C pill, not too many people will care. However if you are off by a few nanograms of estrogenic EDCs, that can be a very big problem.
IC: What are estrogenic endocrine (e2) disruptors? What types of cosmetic/personal care ingredients are potentially (or more likely to be) e2 disruptors?
Gordon: Estrogenic endocrine disruptors are a group of chemicals that can alter the normal levels of the hormone estrogen in humans and wildlife populations. The problem with altering hormonal levels is particularly important in developing fetuses and young children. Altering their hormonal levels can alter their life course. The biggest concern is early onset of cancers, but another big issue is precocious puberty. Puberty now starts two years younger than when we were kids. This will lead to precocious onset of several forms of cancer, i.e., breast and prostate cancers.
There are several types and brands of cosmetics that use chemicals that act as endocrine disruptors. We have tested concealers, eye shadows and sunscreens, and several have shown high levels of estrogenic endocrine disruptors. One study with sunscreen showed very high levels of estrogenic endocrine disruptors in children’s formulas. There are several SPF active ingredients such as methoxycinnimate and 4MBC that are considered endocrine disruptors.
IC: What does testing for endocrine disruptors involve/entail?
Gordon: Currently only data form bioassays is being accepted by regulatory agencies for endocrine disruptor testing. Analytical testing methods (HPLC, GC/MS and LC/MS) have too much potential for a false negative—when the testing lab states there are no EDCs in the product, where in fact there are EDCs in the product. There are several validated bioassays for the detection of EDCs.
Quite simply, companies can just ship their product to a testing lab and have the lab do the analysis. The lab will issue a report with data useful to make any determinations needed for that product. However, for a product lot to be labeled as being free of EDCs, that specific lot of that product must be tested.
IC: Is testing and analysis necessary in order to comply with current regulations?
Gordon: There are no current regulations for EDCs in cosmetics in the United States; however the European Union (EU) is very close to adding regulations. U.S. companies currently doing testing are trying to get ahead of the curve, as well as a desire to market in Europe. U.S. and world consumers are becoming more educated on EDCs and are demanding safer products. This trend right now seems to be more consumer driven than regulatory driven in the United States.
IC: How can a cosmetic company benefit from a bioassay?
Gordon: Cosmetic companies can benefit from bioassays from a couple of main points. First, bioassay data is the only data currently being accepted by regulatory agencies. Second, in vitro bioassays do not use animals in testing and the data is equally accepted for validated bioassays. This is a very good marketing point for cosmetics companies.
The Alion ER Assay™ launched its e2 FREE™ logo program. This is a logo the manufacturer can place on its packaging for specific lots of its product that have been tested and shown to have no detectable levels of estrogenic EDCs. Only those lots of those products that have been tested can carry the logo. This will assure the consumer that this product has been independently tested to contain no detectable levels of estrogenic EDCs.
Alion Science and Technology offers bioassay solutions to help ensure product safety and meet federal, state and local regulations. Its Alion ER Assay™ uses the BG1-ER in vitro bioassay system, which has been approved by ICCVAM in the United States, ECVAM in the European Union and JaCVAM in Japan.
