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cGMP Compliance Testing

Genysis Labs can offer a variety of testing options and, from concept to manufacturing, help to ensure that your material or finished product is consistent and cGMP compliant from one lot to the next. Through validation testing and routine lot testing, our partnership will help to maintain ongoing care for both your product and your customers.

What is Proposition 65?

Prop 65 is a law passed by California to protect its residents from toxic substances that may cause cancer or birth de­fects. It was formerly known as the Safe Drinking Water and Toxic Enforcement Act of 1986. The goal of Prop 65 is to reduce or eliminate exposure to toxic substances. Under this law, no food or supplement product may be sold into California unless it is below specific arsenic, cadmium, lead, and mercury exposure levels and poses no significant risk. For the food and supplement industry, Prop 65 compliance requires testing that certifies whether or not a product can be sold in California.

Arsenic, cadmium, lead, and mercury are some of the substances officially listed by California to cause cancer, birth defects or other reproductive harm. The state of California enforces this law in two ways: by requiring businesses to provide a clear and reasonable warning informing the consumer of the exposure risk or by prohibiting the substances above the designated legal limit.

Does Prop 65 affect my company?

All companies included in the regulated community (raw material vendors, manufacturers, finished product customers, etc.) may not knowingly release a chemical that the state of California has recognized to be toxic when that chemical will come in contact with drinking water. In short, a product with levels of heavy metals above the state limit is in violation, and those raw material or finished good companies, including those that manufacture, are in violation as well.

How can I make my product Prop 65 compliant?

Raw Material Compliance: Raw material compliance is as simple as testing on a routine basis. Genysis Labs can work with your company to set up a testing plan for your materials based on the specific needs of your company.

Finished Product Compliance: Genysis Labs has a unique approach to Prop 65 compliance for finished products. Through a series of tests, Genysis Labs can narrow down the specific ingredient, or ingredients, that are causing your product to be out of compliance. Depending on the number of ingredients within a formula, Genysis Labs can determine the heavy metal drivers in your product in an average of 2–3 rounds of testing.

Why Choose Genysis Labs?

Prop 65 is becoming more and more important in the industry, not only for finished product companies but also for manu­facturers and raw material suppliers. It is an industry effort to test raw materials going into finished products as well as the finished goods themselves, and Genysis Labs is joining the effort to help you keep your materials Prop 65 compliant.

Choosing the right laboratory is essential. With state of the art equipment, value-based testing, and better than average lead times, Genysis Labs allows you to employ our reputable laboratory services so you don’t have to invest in the expense of an in-house laboratory. Genysis Labs uses state of the art Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) and a Direct Mercury Analyzer (DMA) to test for heavy metals contamination. Because we pair the Perkin Elmer NexION 300 ICP-MS, which is optimized for stability and productivity in analyzing trace metals, with the innovative mercury measuring system of the Milestone DMA, our process features lower detection limits than testing by ICP-MS alone.<br/
Additionally, Genysis Labs’ ICP-MS analysis is in process of ISO 17025 accreditation for our current test methods as part of our stride toward becoming a part of an internationally recognized standard of quality for testing laboratories.