Regulatory Affairs

PHACT™ Neat Resins (A1000P, S1000P) are suitable for food contact applications and has compliance with a number of food contact regulations around the globe. Below is a sample of the data from the US, if you need data on Europe, Australia, Canada, Japan, Korea, Mexico, South America, Taiwan, or another geographic region please contact us.

As supplied from our factory, the following grades comply with the following requirements:

A1000P

In the US under FCN 2281 (Food Contact Notification) which is inclusive of all food types with the limitation of condition of use B-H.

As supplied from our factory, the following grades comply with the following requirements:

S1000P

In the US under FCN 2330 (Food Contact Notification) which is inclusive of all food types with the limitation of condition of use B-H.

More information about the FCN process or current list of materials can be found on FDA’s website at: www.fda.gov/food/ingredientspackaginglabeling/packagingfcs/notifications/default.htm

We urge all of our customers to perform GMP (Good Manufacturing Procedures) when constructing a package so that it is suitable for the end use. Please note that it is the responsibility of both the manufacturers of finished food contact articles as well as the industrial food packers to make sure that these articles in their actual use are in compliance with the imposed legislation.

Across the globe, regulations exist for local environmental authorities to evaluate materials to assure the protection of human health and the environment from any unreasonable risks associated with chemical substances. Ingeo, as supplied from the factory gate, complies with the below global chemical inventories:

2003D

3001D

3052D

3251D

4032D

4043D

4060D

6202D

6252D

6400D

6752D

8251D

United States (TSCA) Listed

Prop 65 Not listed

European Union (EINECS)/REACH Compliant

Japan (ENCS) Listed

Australia (AICS) Listed

Korea (KCL) Listed

Philippines (PICCS) Not listed

China (Inventory of existing chemical substances) Listed

If you need further data on chemical control law status in other regions of the world, please contact us.

Triggers of allergic responses are antigens, often proteins, which can be found in air, food, and water. In the case of corn allergens, profilin, a protein, has been identified in corn and in many other plant (food) extracts. When food is heated past the heat-labile point, its chemical configuration changes. Due to the extreme heat and numerous processing steps to convert corn into our feedstock and then to Ingeo, it would not contain immunologically reactive profilin and therefore no concerns regarding allergic reactions from Ingeo.

Ingeo biopolymer does not contain any known amounts of components derived from the ingredients listed in Directive 2003/89/EC and its amendments regarding allergens.