EFSA Reviews Three Novel Foods for Use in Infant Formula

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June 30, 20223E Regulatory Research TeamBlog

In response to a request from the European Commission (EC), the European Food Safety Authority (EFSA) issued two separate opinions on the safety of three novel food (NF) ingredients. The first opinion, regarding an extension of the current acceptable uses of 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) as NF ingredients, was issued on 4 May 2022. The second, regarding the use of bovine milk osteopontin (bmOPN) as an NF ingredient, was issued on 6 May 2022. All three NF ingredients are being considered for use in vulnerable populations—namely infants and children under three years of age. The opinions were provided pursuant to the requirements of Regulation 2015/2283/EU on Novel Foods.

3E Review 

The EFSA Panel on Nutrition, Novel Foods, and Food Allergens (NDA Panel) evaluated the NF ingredients in terms of their composition and proposed conditions of use, in accordance with administrative and scientific requirements for NF applications referred to in Article 10 of Regulation 2015/2283/EU on Novel Foods.

The request to extend the acceptable use conditions of 2’-FL and LNnT as NF ingredients was submitted by the company Glycom A/S in October 2019. These NF ingredients are already authorized for use in several food categories, including infant and follow-up formula, beverages for children under three years of age, and baby food, as well as in food supplements for the general public. The purpose of the application is to obtain authorization to use the NF ingredients in food supplements for infants at the same levels already approved by the EFSA for use in young children. According to the opinion, "the current assessment is exclusively focused on the proposed extension of use with respect to the possible impact on safety and nutritional aspects." As the proposed uses of the two NFs for infants are currently either similar or lower than already authorized estimated intake amounts, the NDA Panel concluded that the extension of the use of 2’-FL and LNnT to food supplements intended for infants is considered safe under the proposed conditions of use. 

The request to consider bmOPN as an NF was submitted by the company Arla Foods Ingredients Group P/S in March 2020. According to the opinion, "Bovine milk osteopontin is produced as a source of osteopontin that can be used as an ingredient to provide infants and young children with a supplementary source of OPN in their diets." The proposed applications for the use of the NF include infant and follow-up formulas, as well as beverages for young children (under three years of age), and the proposed level of use would be comparable to the levels of OPN in human milk. While there were several inconsistencies and other issues listed in the six-month study that provided the basis for the NDA Panel’s analysis of bmOPN, the panel did consider the results of the study sufficiently robust to conclude that the NF ingredient does not pose safety concerns and that it should be safe for infants under the proposed conditions of use. 

3E Analysis

To market a novel food or ingredient, companies must apply to an EU member state competent authority for authorization, presenting the scientific information and safety assessment report. The competent authority decides if an additional assessment by the EFSA is necessary. If assessed and approved for use by the EFSA, the European Commission has to approve the assessment and add the NF to the Commission’s Novel Food Catalogue in order for industries to use it. This review process falls under the purview of Regulation 2015/2283/EU on Novel Foods.

The opinions described above are likely to result in the European Commission recommending the approval of both novel food ingredients for use in food supplements for infants and infant formula, respectively.