From food additive bans and obligatory food packaging changes to consumer right-to-know laws and labeling requirements, keeping abreast of the flurry of legislative and policy activity that is impacting the food industry may seem like an impossible task. What makes these shifting paradigms more complicated, but is not being talked about, are the underlying food safety implications associated with many of these evolving standards. At a high level, this article discusses what you need to know about the food safety storm that is brewing and how best to prepare. 

Food Additives

A few examples of the significant efforts being made to drastically alter the makeup of our foods including the U.S. Food and Drug Administration's (FDA's) revocation of the authorization of FD&C Red 3, the Department of Health and Human Services' request for industry to phase out "petroleum-based" synthetic dyes, and state bills targeting the removal of numerous food additives ranging from aspartame and monosodium glutamate (MSG) to titanium dioxide and seed oils. Considering the functional nature of the additives that are central to many of these policies, brand owners will be on the lookout for replacements that can fill the functionality gaps created by the removal of these ingredients.

Brand owners must undertake internal qualification processes to verify that new ingredients will technically perform as they are intended to, which is no small task. However, ingredient changes are also met with a plethora of regulatory obstacles beyond just making sure the substance is "cleared" for its intended use. With any ingredient swap comes corresponding changes to a company's Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan. While this may seem routine, shifting from food ingredients that have been safely used for decades to new substances whose full hazard profile and associated risks may not yet be fully understood can be extremely challenging. Consider, for example, swapping out a synthetic food additive for a natural alternative. The hazards associated with natural extracts are expected to be quite different than their synthetic counterparts and may include increased potential for microbial contamination, presence of mycotoxins, or pesticide residues, to name a few. Now consider that the type of hazards and corresponding risks associated with certain agriculturally derived food ingredients may vary as a function of growing season, growing conditions, region, or even the specific field in which a particular agricultural commodity is grown. It is no longer quite so straightforward. 

Another potentiality that brand owners must be prepared for is economic adulteration of crucial new ingredients. As with any industry, those in the food industry seek consistency in their ingredients. However, in combining rapidly growing demand and potential seasonal product variations in naturally sourced ingredients, for example, it may be tempting for less reputable suppliers to fortify naturally derived ingredients with substances to mask batch-to-batch variations or to extend supplies. 

The shift away from synthetic food additives only scratches the surface of potential complexities associated with food ingredient replacements. Other ingredients on the chopping block in certain states include preservatives that are used in a variety of food products. In addition to the burdens of technical qualification of alternatives and revisions to HARPC plans, substitution or elimination of such ingredients is also more likely to directly influence the recommended shelf life of many products. While internal due diligence may cause modification of "Best By" dates or storage recommendations featured on packaged foods, consumer buying and food storage habits may be slower to change. A food product that has been routinely consumed for years or decades that now spoils faster or requires different storage conditions has the potential to not only increase food waste but may also present different food safety concerns. 

Considered individually, the substitution of a single existing food ingredient for a new alternative may be somewhat routine. However, swapping out multiple functional food ingredients in close proximity has the potential to be exponentially harder. The dynamic relationships between certain food ingredients demands analysis of finished food products to ensure that there are no unforeseen interactions between food ingredients that function ideally when considered independently but perhaps not in concert, and that recipes are specifically tailored to meet necessary requirements. It is not just changes in food additives themselves that food manufacturers need to be aware of when qualifying new materials and updating HARPC plans. Potential interactions of food with packaging materials have also entered the spotlight.

Food Packaging

Adding fodder to growing food safety concerns is the dynamic state of food packaging requirements at the state level. The number of states seeking to tackle the plastic waste problem head-on through shifts from traditional plastics to compostable alternatives, the imposition of minimum recycled content mandates for packaging materials, and the promotion of reusable packaging materials are surging. However, the desire to rapidly shift the packaging paradigm must be tempered by the reality that the regulatory and food safety considerations for new packaging materials are not trivial. 

A switch to dynamic packaging materials (e.g., compostable) that are intended to "return to the earth" after usage need to be carefully evaluated on a case-by-case basis to ensure that packaging materials remain inert while in contact with food. Furthermore, like with certain ingredient shifts, due to inevitable differences in moisture vapor transmission and gas permeability compared to currently used materials, the impacts of new packaging materials on the shelf life of packaged foods must be thoroughly evaluated and appropriately communicated downstream. The dynamic nature of compostable plastics may also demand that the shelf life and storage conditions of the packaging material itself be assessed to ensure that new materials do not deteriorate prior to contact with food or result in interactions with food ingredients. 

Like with food ingredients, packaging material changes—whether that be wholesale changes to packaging composition or simply the incorporation of low levels of post-consumer recycled content—also demand modifications to HARPC plans. However, like with newly developed food ingredients, the primary obstacle in developing an adequate HARPC plan incorporating the use of new or inherently variable packaging materials is that, at this stage, we simply "don't know what we don't know."

Striving to incorporate more post-consumer recycled content into packaging materials is critical to improving circularity, but inadequate plastics recycling rates increases the difficulty of sourcing quality materials. It also leads to more potential variation in materials that are sourced. 

While brand owners and packaging producers understand the complexities and potential food safety risks associated with rapid changes to food packaging standards, it is unclear whether emerging Extended Producer Responsibility (EPR) requirements will acknowledge these limitations and do so consistently. Herein lies another complication: the diversity of evolving state requirements for food packaging. 

State-to-state variations in packaging construction are likely not a practical solution for brand owners. As such, food companies are forced to not only understand requirements imposed on packaging materials on a state-by-state basis, but also make packaging decisions based on the most stringent state requirements, which can change from year to year.

Necessary Next Steps

Ultimately, despite the calls for urgent actions to replace certain food ingredients and packaging components, those in the food supply chain must exercise patience and remember that there is no way to shortcut the appropriate management of change procedures. Qualified individuals should undertake necessary ingredient qualification procedures, exercise appropriate levels of regulatory due diligence, and conduct the necessary hazard/risk assessments required under the Food Safety Modernization Act. 

Legal experts continue to monitor federal, state, and local developments impacting food and food packaging materials and provide strategic assistance to clients navigating this complex and evolving regulatory landscape.