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Subject: FDA

AMPtm Multifunctional Additive Receives U.S. FDA Approval For Expanded Use In Food Contact Applications


BUFFALO GROVE, Ill., Oct. 30, 2018 /PRNewswire/ -- 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 AMPtm 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.

ANGUS Chemical Company is a specialty and fine chemical company dedicated to the development of novel chemistries that help customers deliver enhanced product and process performance. ANGUS is committed to constantly improving products and services by mastering science and technology. The company innovates through its unique nitroalkane chemistry, which harbors the reactivity to create complex molecules for use in a wide variety of applications.

"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:

(1)  coatings at a level not to exceed 0.25% by weight of the mineral pigment, and
(2)  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:

A.    High temperature heat-sterilized (e.g., over 2120 F).
B.    Boiling water sterilized.
C.   Hot filled or pasteurized above 1500 F.
D.   Hot filled or pasteurized below 1500 F.
E.    Room temperature filled and stored (no thermal treatment in the container).
F.    Refrigerated storage (no thermal treatment in the container).
G.   Frozen storage (no thermal treatment in the container).
H.   Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container.
J.    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.

ABOUT ANGUS CHEMICAL COMPANY
ANGUS Chemical Company is a leading global specialty and fine chemical company dedicated to the development of novel chemistries that deliver enhanced product and process performance across a wide range of applications in biotechnology, paints and coatings, personal care, metalworking fluids, energy and other industrial markets. The Company innovates through its unique nitroalkane chemistries, which are produced at fully integrated, ISO 9001-certified manufacturing facilities in Sterlington, Louisiana, USA, and Ibbenbüren, Germany. ANGUS serves its global customers through six regional Customer Applications Centers located in Chicago, Illinois; Paris, France; São Paulo, Brazil; Singapore; Shanghai, China; and Mumbai, India. The Company is privately owned by Golden Gate Capital and is headquartered in Buffalo Grove, Illinois. For more information, visit angus.com.

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FOR ADDITIONAL INFORMATION
ANGUS Media Relations                  
Scott C. Johnson
+1 847-808-3769
[email protected]

 

SOURCE ANGUS Chemical Company



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