An Overview of Non-Intentionally Added Substances (NIAS) in Food Contact Materials and Packaging

Food packaging can consist of polymers, monomers, additives and other substances. To be approved in the EU for use in food contact materials, these substances are governed covered by specific legislative measures and strict migration limits designed to protect consumers from overexposure. These substances are referred to as intentionally added substances.

Potentially present in that same food contact material, however, could be non-intentionally added substances (NIAS). These substances can originate from different sources and pose a threat to the consumer at the end of the supply chain. As a result, manufacturers are expected to limit the presence of these contaminants in their food packaging.

Where do NIAS come from?

NIAS can be categorized in three distinct ways:

  1. Raw material contaminants. Primary aromatic amine intermediates may be present in inks from ink pigments.
  2. Process contaminants. Food packaging can come into contact with biocidal products, lubricants and other substances during processing.
  3. Environmental contaminants. A packaging material environment during transport or storage can introduce contaminants.

To mitigate the possible adverse effects of these contaminants, some NIAS are subject to specific legal limits or regulated within authorized substances.

Achieving Compliance along the Supply Chain

To be in compliance in the EU, manufacturers have to follow Good Manufacturing Practice (GMP) Regulation (EC) No 2023/2006, which requires control of the purity of starting materials. Compliance against Regulation (EC) No 1935/2004 and Regulation (EU) 10/2011 as amended is also required. A risk assessment of NIAS in the production process, and the inclusion of identified NIAS in a Declaration of Compliance (DoC) that is passed along the supply chain are also required for plastics materials.

Business operators have a few different options for dispersing responsibility along the supply chain. The preferred route is generally to accept full responsibility at each stage, where each business operator conducts risk assessments on their products. A choice of shared responsibility is appropriate when compliance may be affected by the customer converting process. For example, ink suppliers confirm areas of compliance and provide necessary information for the printer to demonstrate compliance of the printed food contact material. Transferred responsibility is useful for situations in which the business operator does not or cannot know the final application. In the case of a solvent, for example, the operator confirms complete transfer of responsibility after providing all relevant information, such as chemical identity, physical properties, purity, etc.

Simplifying the Process

There are a few steps that can be taken to simplify a NIAS assessment:

  • Obtain the most complete disclosure as you can regarding the chemicals used in a food contact material.
  • Attempt to establish the source of any NIAS, as they could be connected to intentionally added substances (IAS).
  • Know that some NIAS may be included within the specific migration limit of an authorized additive from which it is derived.
  • Verify that the identified NIAS is not an IAS by checking against Regulation (EU) No 10/2011 as amended.

To learn more about why NIAS arise, specific legislation related to NIAS, estimating the effects of NIAS, and the steps to take when NIAS is found, from conducting a study to reporting results, download our recent webinar, “A Beginner’s Guide to NIAS”, presented by Smithers Pira expert Tony Lord.

Download the webinar