ANGUS Chemical Company (“ANGUS” or “Company”), a leading global manufacturer and marketer of specialty chemicals, announced today that the U.S. Food and Drug Administration (FDA) has issued an expanded Food Contact Substance Notification (FCN) for the Company’s flagship AMP™ multifunctional additive (1-amino-2-methyl-1-propanol, CAS. Reg. No. 124-68-5). The expanded FCN approval, which came into effect October 17, 2018, covers the use of AMP as a dispersant for mineral pigment suspensions used as a component of fillers and coatings for paper and paperboard.
“For more than 40 years, the use of our AMP amino alcohol has been proven safe and effective in a wide variety of regulated and industrial applications,” said Dr. Pam Spencer, Senior Director, Regulatory, Product Stewardship and Quality at ANGUS. “This expanded food contact approval by the FDA further strengthens the position of our AMP multifunctional additive as a formulating tool of choice for applications where safety and performance are critical, especially at high cooking temperatures.”
ANGUS’ AMP multifunctional additive provides exceptional performance as a dispersant for natural clays, titanium dioxide and calcium carbonate pigments widely used in paper and paperboard packaging applications. The unique chemistry of AMP provides superior wetting and pigment stabilization allowing formulators to potentially eliminate the use of other surfactants and dispersants while increasing pigment loading and improving the properties of the final paper packaging.
The most recent FCN approval (001917) specifies that AMP can be used as a component of:
- coatings at a level not to exceed 0.25% by weight of the mineral pigment, and
- fillers at a level not to exceed 0.05% by weight of the mineral pigment.
Finished paper and paperboard using AMP may contact all food types under the following Conditions of Use established by the U.S. FDA:
- High temperature heat-sterilized (e.g., over 2120 F).
- Boiling water sterilized.
- Hot filled or pasteurized above 1500 F.
- Hot filled or pasteurized below 1500 F.
- Room temperature filled and stored (no thermal treatment in the container).
- Refrigerated storage (no thermal treatment in the container).
- Frozen storage (no thermal treatment in the container).
- Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container.
- Cooking at temperatures exceeding 2500 F (microwave-only container applications).
AMP multifunctional additive is not approved for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
For more information, visit with an ANGUS Life Sciences representative at the upcoming CPhI Worldwide event, Stand 5C70, October 9 -11, at IFEMA – Feria de Madrid in Madrid, Spain, or visit www.angus.com.