If avoiding singular chemicals or plastic does not solve the problem of EA, then how can it be addressed? The answer is straightforward. In order to make products completely EA-free, all materials, processing, and product components should be developed and molded EA-free.
productpure has worked with its partners utilizing research generated over 15 years to develop the first certified PlastiPure-Safe™ EA-free baby bottle. This research was completed with significant support and collaboration from many US federal agencies such as the National Science Foundation, National Institute of Environmental Health Sciences, National Toxicology Program, and ICCVAM/NICEATM (consortium of 16 US federal agencies including the EPA, FDA, USDA, and NIH).
productpure follows a comprehensive process to make EA-free products. Not unlike drug screening, very large numbers of candidate chemicals, and later formulations, must be screened and tested to determine appropriate EA-free materials, colorants, additives, processing aides, and other substances necessary to produce a completely EA-free product. Candidate chemicals and materials must meet these safety criteria before testing and final approval for use in certified EA-free products.
Model: The first step is to create candidate formulations working with strategic partner PlastiPure. PlastiPure has molecular models which provide specific rules on which chemicals are likely to bind, or not bind, to estrogen receptors. Using this information candidate chemicals, additives, processing aids, materials, along with other parts of a total material formulation can be initially evaluated.
Simulate: After review of these models, candidate chemicals and formulations can be simulated in proprietary computer programs to see if they have a high affinity to bind with estrogen receptors. Those chemicals and formulations which indicate significant binding should be avoided. As an example using this analysis, scientists have readily seen that estrogen receptor binding to BPS is not much different to BPA, indicating the limited value in switching from one BPA structural analogue to another in avoiding EA.
Sample: The best chemical candidates can now be formulated and compounded into workable materials (or identified if already available).
Form: These candidate materials are then formed into plaques, film, or product components.
Stress: All candidate materials should be subjected to different stresses simulating long-term use for the intended consumer products. Examples of stresses simulated are sunlight, dishwashing, microwaving, and boiling.
Extract: After stressing, these materials are exposed to food and drink simulants. Extraction simulants comprising mixtures of water and ethanol can represent leaching profiles for many foodstuffs. After volatile chemicals are extracted, the candidates are prepared for EA testing.
Test Materials: Two highly sensitive robotic bioassays are used to detect EA. These implementations of the BG1-Luc and the MCF7 bioassays have been heavily optimized for their sensitivity, repeatability, and reliability, going through years of development, collaboration with government scientists, and international validation studies. Hormonal chemicals have an effect on the human body on the order of parts per billion to parts per trillion concentrations. It is very important to use highly sensitive tests to detect EA or companies can easily falsely report their products as EA-free when they have used an insensitive test.
Process: After materials and processing aides have been approved, molding companies must now be evaluated and trained to make EA-free components without contaminating the end product. While most processors can implement the EA-free procedures, their quality assurance and tracking programs must support a high level of consistency and compliance for products to me made reliably EA-free.
Test Components: Once the processor has been approved, testing of all the components of the consumer product may now commence. All components which come into contact with foodstuffs or the mouth must pass EA-free testing.
Certify: The PlastiPure-Safe™ EA-free certification seal is displayed on product packaging so consumers know that their product meets this more comprehensive safety standard. For continued certification, samples from production must continue to pass the EA-free testing on an ongoing basis.
While this EA-free process seems complex, with training and the right know-how, implementation is not difficult for companies that have good quality assurance and quality control programs. The methods are reasonable for production, and once running at high volumes, the costs are comparable to non EA-free manufacturing.
productpure will continue to develop and manufacture the safest products that we can, to meet the certified EA-free standard. We challenge other companies to do the same. The EA-free process used to develop the productpure baby bottle can be used in launching additional highly desirable products including other consumer products, foods, cosmetics, and packaging. We think people should have an option for comprehensively EA-free products for their families.