It’s easy to take for granted the safety of the food we put into our bodies. But in today’s global economy, food items, food additives, and food packaging materials can be sourced from all over the world and these complex supply chains create unique challenges for those responsible for ensuring the safety of our food supply. In the U.S., food safety is regulated under the FDA Food, Drug, and Cosmetic (FD&C) Act as amended by the Food Safety Modernization Act (FSMA).

Experien Health Sciences offers the following food safety services to help companies in their efforts to comply with the FD&C Act and FSMA:

  • Filing Food Contact Notifications (FCN) with the FDA.
  • Determining if substances are Generally Recognized as Safe (GRAS) and filing GRAS Notifications with the FDA.
  • Reviewing the compliance status of Food Contact Substances (FCS).
  • Hazard Review / Hazard Analysis of chemical substances used in food processing that may accidentally be incorporated into food, or that may be incorporated because of process changes made for economic and environmental benefits.
  • Implementing cGMP and auditing suppliers, distributors, and re-packers.

Food Contact Notifications (FCN) must be submitted to FDA prior to marketing a Food Contact Substance (FCS). A FCS is a type of Indirect Food Additive and is any chemical component of a Food Contact Material (FCM), Food Contact Article, and/or Food Packaging Material that can migrate into food and be consumed but is not intended to be added directly to, become a component of, or have a technical effect in or on the food. Food Contact Notifications can require a significant amount of data to allow for a reasoned estimate of dietary intake of the FCS and to inform the decision-making process. Knowing the types of Food Contact Materials, Food Contact Articles, and Food Packaging Materials to be used, the conditions of use, the extent to which the FCS could migrate to food (migration testing) and having adequate toxicological data are all critical elements of establishing an suitable safety profile for FDA to review. FCS approvals are applicable only to the manufacturer or supplier listed in the FCN.

Generally Recognized as Safe (GRAS) substances that are incorporated into food are excluded from the definition of food additive and do not require pre-market review by the FDA. To qualify, all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts, and there must be a reasonable certainty of no harm under the conditions of its intended use and have the same quantity and quality of information that would support the safety of a food additive. GRAS determinations need not be notified to FDA, but FDA strongly encourages a GRAS Notice. Under FDA’s “Threshold of Regulation” exemption, substances present in food below 0.5 ppb are, in the absence of mitigating factors, GRAS based on low dietary exposure. Higher thresholds have also been recognized of the substances meet certain toxicological criteria.

Reviewing the compliance status of Food Contact Substances (FCS) is a determination of whether the use of a chemical substance in a FCM is permissible under FDA regulations. Under these regulations, compliance can be achieved a number of ways including through the FCN process, the GRAS process, the Food Additive Petition process, as a Prior Sanctioned Substance, as an approved Color Additive or Colorant, and/or by exemption under the Threshold of Regulation rule. To assure compliance throughout what can be a complicated supply chain, manufacturers of food contact substances, materials, packaging materials and other articles, and manufacturers of the food being processed or packaged, each have a role to play. Typically, compliance assurance is communicated by issuance of a compliance declaration or a “Letter of Guaranty” in accordance with Section 303 of the FDA FD&C Act.

Hazard Review / Hazard Analysis of chemicals used in support of food processing is similar to a GRAS determination but differs on the basis that the chemicals in question are not intended to be incorporated into food. Cooling water and boiler chemicals, cleaning products, lubricants, and similar products typically fall into this category and can either be accidentally incorporated into food by leaks or process upsets or because of process changes made for economic and environmental benefits. Under FSMA, food manufactures must perform hazard analysis and implement risk-based preventive controls to keep our food safe. As part of these reviews, chemical suppliers are increasingly being asked to ensure the chemicals they supply will not place the food supply at risk.


Learn more about how Experien Health Sciences can help you.