Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on UV-treated milk as a novel food submitted pursuant to Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. The assessment follows the methodology set in Commission Recommendation 97/618/EC and is based on the data supplied in the original application, the initial assessment by the competent authority of Ireland, the concerns and objections of other Member States, and the responses of the applicant.
The novel food is cow’s milk (whole, semi-skimmed or skimmed) to which a treatment with ultraviolet (UV) radiation is applied after pasteurisation in order to extend the shelf life of the milk. The treatment of the milk with UV results in an increase in the vitamin D3 concentrations by conversion of 7-dehydrocholesterol to vitamin D3. Specifications of the novel food include the intended vitamin D3 content (whole milk: 0.5–3.2 µg/100 g; semi-skimmed milk: 0.1–1.5 µg/100 g; skimmed milk: traces), and total viable count (< 100 colony-forming units/mL). The target group is the general population with the exclusion of infants (up to 1 year of age).
The applicant provided compositional data on macro- and micro-nutrients in milk subjected to UV treatment. The UV-treated milk contained significant amounts of vitamin D3, whereas the contents in the control milk were below the limit of detection. Apart from vitamin D3, there were no significant differences in the nutrient content of milks treated with UV as compared to control milk. From the data provided, the Panel considers that the formation of lipid or protein oxidation products is not of safety concern. The Panel, therefore, considers that the provided compositional data, the specifications and the data from batch testing do not give rise to safety concerns.
The process conditions of the UV treatment have been provided by the applicant. Considering that there are no relevant changes in nutrient composition in the milks following the proposed UV treatment, the Panel considers the specified parameters as acceptable. The Panel concludes that 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 cow’s milk is UV treated and contains the maximum proposed vitamin D3 concentrations, it is unlikely that tolerable upper intake levels established by EFSA for children aged 1–10 years (50 µg/day) and adolescents and adults (100 µg/day) will be exceeded.
UV-treated milk is comparable to non-UV-treated milk, except for the vitamin D3 content. No adverse effects regarding the contribution of milk to nutrient intakes are expected from the consumption of UV-treated milk in substitution of non-UV-treated milk. The Panel considers that the novel food is not nutritionally disadvantageous.
Information was provided on the microbiological status of the novel food. The Panel considers that the data provided do not give rise to concerns with regard to the microbiological quality of the novel food.
With regard to allergenicity, the Panel considers that the risk of allergic reactions to the novel food is not dissimilar to that associated with conventional milk.
The Panel concludes that the novel food, UV-treated milk, is safe under the intended conditions of use as specified by the applicant.