Scientific Opinion on the safety of UV‐treated bread as a novel food EFSA Panel on Dietetic Products, Nutrition and Allergies

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to carry out the additional assessment for UV-treated bread as a novel food (NF) in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. The NF is bread to which a treatment with UV radiation is applied after baking in order to convert ergosterol, which is present in bread as a result of yeast fermentation, to vitamin D 2 . The provided compositional data, the specifications (i.e. vitamin D 2 content of 0.75-3 μg/100 g in the UV-treated bread, 1-5 g/100 g of yeast in the dough) and the data from batch testing do not give rise to safety concerns. The data provided on the production process are sufficient and do not give rise to safety concerns. The Panel considers that even if it is conservatively assumed that all consumed breads are UV-treated and contain the maximum proposed amount of 3 µg vitamin D 2 /100 g, it is highly unlikely that tolerable upper intake levels for vitamin D, established by EFSA for various age groups, will be exceeded. The NF is not nutritionally disadvantageous. Under certain conditions, UV treatment may result in reactions of biomolecules. However, the levels of potential reaction products that may be formed under the employed conditions are low compared with the reactions induced by the baking process. Therefore, the Panel considers that it is not necessary to perform additional analyses and that the absence of toxicological studies with the novel food is acceptable. The risk of allergic reactions to the NF is not dissimilar to that associated with conventional bread. The Panel considers that bread enriched with vitamin D 2 through UV treatment is safe under the conditions of use as specified by the applicant. The NF is bread to which a treatment with UV radiation is applied after baking in order to convert ergosterol, which is present in bread as a result of yeast fermentation, to vitamin D 2 (ergocalciferol). Specifications of the NF include the intended vitamin D 2 content (0.75-3 μg/100 g) in the UV-treated bread and the amount of yeast (1-5 g/100 g) required in the dough in order to achieve the amount of vitamin D 2 . © EuropeanThe applicant provided compositional data on macro-and micronutrients in various types of bread subjected to the UV treatment at pilot and commercial scale. The UV-treated breads contained significant amounts of vitamin D 2 , while the contents in the control breads were below the limit of detection. The contents of water, protein, fat, carbohydrate, fibre, different groups of fatty acids, vitamin E and B vitamins in the UV-treated breads were comparable to those in the control breads. The UV treatment results in the formation of vitamin D 2 in only a thin outer layer (i.e. crust, 2-3 mm) of the bread. Peroxide values and folate contents in crust and crumb following UV treatment were comparable to those determined in the control. The Pa...

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“…The Panel also noted that the tachysterol concentrations are lower than those reported in previous EFSA Scientific Opinions on UV-treated novel foods, which did not give rise to safety concerns (EFSA NDA Panel 2014, 2015, 2016c. The applicant indicated a maximum use level of the NF of 2.25 lg/100 g for food products other than beverages that would result in intakes of lumisterol and tachysterol of 0.0005 lg/100 g and 0.0003 lg/100 g, respectively.…”

“…The NDA Panel noted that the tachysterol concentrations are lower than those reported in previous EFSA Scientific Opinions on UV-treated novel foods (EFSA NDA Panel, 2014, 2015, 2016c. The exposure to these compounds from the NF can therefore be considered not to be of toxicological relevance.…”

“…UV irradiation technique to enhance the content of vitamin D has been used in other approved novel foods evaluated by EFSA: UV-treated baker's yeast (Saccharomyces cerevisiae) (EFSA NDA Panel, 2014), UV-treated bread (EFSA NDA Panel, 2015) and UV-treated milk (EFSA NDA Panel, 2016c). All of them are currently under the Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods.…”

“…Based on previous EFSA assessments on UV-treated novel foods (EFSA NDA Panel, 2014, 2015, 2016c that are currently authorised, the Panel considers the specified parameters, including the range of wavelength for the UV treatment, as being similar.…”

“…For previous scientific opinions on similar NFs (on UV-treated baker's yeast, bread or milk), no toxicological studies were considered necessary (EFSA NDA Panel, 2014, 2015, 2016c. For previous scientific opinions on similar NFs (on UV-treated baker's yeast, bread or milk), no toxicological studies were considered necessary (EFSA NDA Panel, 2014, 2015, 2016c.…”