26 Nov 2021

Regulatory and Safety Hurdles

In a world where consumers are becoming more conscientious about meat consumption and its environmental impact, the food industry is actively looking into sustainable protein alternatives.  In the European Union (EU), approval under Regulation (EU) No 2015/2283 on novel foods1 is a key element to getting these substances to market.  There have been numerous EU approvals for novel protein sources over the past 20 years— from bovine milk basic whey protein isolate and coagulated potato proteins and hydrolysates to rapeseed protein isolate.  More recently, the number and variety of novel protein applications submitted to the European Commission, including those sourced from legumes, fungi, microalgae, and insects, among others2, has grown further. 

Novel food approval for alternative proteins when establishing a regulatory strategy, including allergenicity concerns, toxicology testing, and nutritional considerations.

By definition, novel proteins will have very limited or no history of safe consumption.  As all proteins have the potential to induce sensitization following consumption, allergenicity considerations are often a pivotal component of the safety evaluation.  In the absence of predictive in vivo models of allergenicity, in silico bioinformatics evaluations using homology analysis and proteomic characterization can be used as a Tier I approach to determine allergenic potential.  In situations where the outcome of Tier I testing suggests the potential for cross-reactivity to a major allergen, additional Tier II testing using in vitro assays [e.g., digestion studies, immunoglobulin E (IgE) binding, histamine degranulation] with serum/blood cells from sensitized individuals, or further in vivo studies in allergic subjects, may be required to obtain adequate hazard characterization information for the risk assessment.

As common macronutrients that are digested to amino acids following consumption, novel proteins tend to display lower toxicity potential than other novel foods.  However, strong scientific justification is still necessary to omit the toxicity testing component of the hazard characterization process.  For example, it may be possible to avoid animal testing in situations where the food source has been consumed to a significant degree and the manufacturing process does not introduce inherent substances of concern—this was the case for mung bean protein, which recently received a positive European Food Safety Authority (EFSA) opinion3.  If available, animal toxicity studies conducted using related material may be leveraged to evaluate safety of a novel protein and avoid the need for product-specific animal toxicity studies, provided sufficient bridging information is available to demonstrate that the test articles are applicable to the novel protein.  This approach was used to support the safety of 4 novel insect protein sources in positive EFSA opinions published this year4,5,6,7.  Where there is insufficient information to characterize the hazard of a novel protein, animal toxicity studies are typically necessary; however, limitations in achieving sufficiently high doses for use in establishing a margin of safety relative to a no observed adverse effect level (NOAEL) should be recognized.

The next big hurdle regulatory bodies will face is the approval of cell-cultured ("lab grown") meats.  Looking at the global picture, the Singapore Food Agency has approved lab-grown chicken nuggets, while the United States Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) are currently working on a joint venture for the approval of these products in the region.  To date, while it is expected that cell cultured meats will be subject to premarket approval under the novel foods process, the regulatory elements of its implementation are not clear in the EU or the UK.  Taking a balanced approach to the regulatory process will be critical for promoting and supporting innovation in these markets.

We're Here to Help:

Intertek has extensive experience with overcoming regulatory hurdles and developing unique strategic pathways.  If you have any questions and would like to speak to one of our experts, we will be available onsite at Food Ingredients (Fi) Europe 2021 from November 30 to December 1, 2021.  To book a meeting with our team, visit: https://www.intertek.com/assuris/meet-intertek-at-fi-europe-2021/.  

To learn more about how we can support your business, visit: https://www.intertek.com/food/consulting/.



Danika Martyn, 
Director, Europe, Food & Nutrition, 
Intertek Assuris



Danika Martyn works with clients to develop regulatory strategies for new ingredients and she works to critically review, evaluate and interpret analytical and scientific data as part of safety assessments for substances added to food.  She has considerable experience in the authorisation of novel foods, food additives and enzymes in the European Union.  Working alongside regulatory authorities, she has active role in stewarding applications through the approval process.  She is a recognized expert in dietary exposure assessment and has extensive experience in modeling dietary intake data to estimate human exposure to food chemicals, ingredients and nutrients.


Kirt Phipps, 
Senior Manager, Toxicology and Regulatory Affairs, Food & Nutrition, 
Intertek Assuris



Kirt Phipps is involved in the preparation and stewardship of applications for regulated products (novel foods, food additives and food enzymes) in the European Union (EU) and United Kingdom (UK).  He is responsible for resolving complex regulatory and toxicological queries raised by the European Commission and the European Food Safety Authority (EFSA), which has led to the ultimate approval of numerous applications. He is also responsible for the placement and monitoring of toxicology studies at Intertek Assuris, including selection of an appropriate CRO, study design and dose level selection, overseeing in-life phases and critical review of draft reports.  This is an essential component of the risk assessment for substances to be added to foods.

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