05 April 2022

Statement of Compliance

Subject: FDA Regulations

Regarding: UV Curable Products
In accordance with current FDA regulations UV Curable products may be used for the printing of
the non-food contact side of primary food packaging when the material printed upon acts as an
appropriate functional barrier to ensure that contact with ink/coating components and the food
content or filling does not take place. The converter of the finished article bears the responsibility
to ensure that the end use product is fit for its intended purpose. Provided that the products are
correctly applied and cured, and that the food packaging is designed in a way that there exists an
appropriate functional barrier which prevents the coating components from contacting the food,
the products will not hinder compliance of the finished article with the existing provisions for FDA
Title 21 CFR 175-178 requirements concerning incidental food contact.
UV Curable products are not designed nor approved for direct contact with food or
pharmaceuticals, nor prolonged contact with human tissue as in cosmetics or indwelling medical
devices.
USP Class VI: Our ink and additive products are not designed nor approved for use with medical
products that are in extended contact with human tissues. For this reason, products are not
certified to USP Class VI standards nor ISO 10993.
Printer Safety - Much can be done to ensure the safety of printed food containers by making sure
that all equipment including curing lamps, reflectors and all appropriate variables such as ink film
thickness, substrate, printing speeds, etc. are conducive to proper ink application. Less than
optimal application / incomplete cure can affect the final result concerning ink transfer during
nesting or migration of components through the label or container wall.
The statements made are according to our present knowledge. They do not absolve the user from
the responsibility to determine suitability of our products for their process. No legal implication
should be derived from our statements, since explicit guarantees with respect to product
performance are neither expressed nor implied. Current laws and regulations should be observed
by the consignees of our products as prudent risk management.
Sincerely,

Richard N. Harrison
Regulatory Affairs

Indirect Food Additive - In general, these are food additives that come into contact with food as part of
packaging, holding, or processing, but are not intended to be added directly to, become a component, or
have a technical effect in or on the food..Jan 4, 2018 www.fda.gov/food/food -ingredient-packaging-
terms