The guidance, published last month, is designed to gather comments from industry on the process of petitioning FDA for a safety evaluation of additives used both in foods and in food packaging.
Antimicrobial food additives, as defined by the regulatory agency, are additives used to control microorganisms such as bacteria, viruses, fungi, protozoa in or on food or food contact materials. FDA's definition includes sources of radiation for treating food.
The agency said its guidance is intended to set out all data requirements for petitions, in order to ensure that sufficient information is provided and supporting studies are conducted in an adequate manner.
The standard used to determine whether a food additive is safe for use is "reasonable certainty of no harm". The agency works together with the US Department of Agriculture (USDA), through a Memorandum of Understanding, to evaluate the safety of ingredients for use in meat and poultry products.
According to FDA, in order for approval to be obtained, the agency must examine a number if factors, including the intended effect of the ingredient, the quantity required to achieve this effect, and a safety assessment of the additive.
A food additive regulation will not be established if the proposed use of the additive would be misleading to consumers, for example by making a product appear to be fresher or of greater value than it actually is.
If a tolerance level is required, FDA says this must not be fixed at a level higher than that reasonably required to achieve the intended effect. In addition, the agency said it may require additional microbiological data to supplement the additives safety assessment.
Amongst the data required to demonstrate that a food additive achieves its intended effect, is the chemical identity of the component, its intended effect and a description of the conditions of use and any limitations of these conditions. This includes the types of foods it is designed to be used in, its proposed use level or range, the temperature range of use, the method of application, and any post-processing steps.
In addition, FDA requires antimicrobial effect data, including full reports of the efficacy studies, and recommendations regarding proposed use, as well as labeling suggestions.
To access the full guidance document, click here .