Scientific Opinion on the safety of ‘heat-treated milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food

TY - JOUR

T1 - Scientific Opinion on the safety of ‘heat-treated milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food

AU - Tetens, Inge

AU - Sjödin, Anders Mikael

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Following a request from the European Commission, the EFSA NDA Panel was asked to carry out the additional assessment for ‘pasteurised milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food (NF) in the context of Regulation (EC) No 258/97. Pasteurised or ultra-high-temperature-treated milk is used for the fermentation process with B. xylanisolvens DSM 23964. After fermentation the product is heat treated for one hour at 75 °C to ensure the absence of viable B. xylanisolvens DSM 23964. The Panel considers the information provided on the identity and characterisation of B. xylanisolvens DSM 23964 to be sufficient. The production process encompasses standard techniques used by the dairy industry, is sufficiently described by the applicant and does not give rise to safety concerns. The Panel considers that the information provided on the production process and on the content of vitamins B2 and B12 and furosine in heat-treated fermented milk products does not give rise to concerns regarding disadvantageous nutritional effects. The Panel considers that the microbiological data provided do not give rise to safety concerns. The Panel also notes that a pilot study and a RCT over six weeks with 140 volunteers receiving daily doses of a spray-dried heat-treated fermented milk product containing intakes of up to 1 × 1012 inactivated bacterial cells of B. xylanisolvens DSM 23964 were provided. No clinical effects related to the treatment were observed in the two studies. Although no information has been provided to conclude on the risk of allergic reactions caused by the NF, the Panel considers that it is unlikely that its allergenic potential is dissimilar to that of other fermented dairy products. The Panel concludes that the NF ‘heat-treated milk products fermented with B. xylanisolvens DSM 23964’ is safe for the proposed uses and at the proposed use levels.

AB - Following a request from the European Commission, the EFSA NDA Panel was asked to carry out the additional assessment for ‘pasteurised milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food (NF) in the context of Regulation (EC) No 258/97. Pasteurised or ultra-high-temperature-treated milk is used for the fermentation process with B. xylanisolvens DSM 23964. After fermentation the product is heat treated for one hour at 75 °C to ensure the absence of viable B. xylanisolvens DSM 23964. The Panel considers the information provided on the identity and characterisation of B. xylanisolvens DSM 23964 to be sufficient. The production process encompasses standard techniques used by the dairy industry, is sufficiently described by the applicant and does not give rise to safety concerns. The Panel considers that the information provided on the production process and on the content of vitamins B2 and B12 and furosine in heat-treated fermented milk products does not give rise to concerns regarding disadvantageous nutritional effects. The Panel considers that the microbiological data provided do not give rise to safety concerns. The Panel also notes that a pilot study and a RCT over six weeks with 140 volunteers receiving daily doses of a spray-dried heat-treated fermented milk product containing intakes of up to 1 × 1012 inactivated bacterial cells of B. xylanisolvens DSM 23964 were provided. No clinical effects related to the treatment were observed in the two studies. Although no information has been provided to conclude on the risk of allergic reactions caused by the NF, the Panel considers that it is unlikely that its allergenic potential is dissimilar to that of other fermented dairy products. The Panel concludes that the NF ‘heat-treated milk products fermented with B. xylanisolvens DSM 23964’ is safe for the proposed uses and at the proposed use levels.

KW - Faculty of Science

KW - Bacteroides xylanisolvens

KW - Fermentation

KW - Dairy

KW - Novel food

U2 - 10.2903/j.efsa.2015.3956

DO - 10.2903/j.efsa.2015.3956

M3 - Journal article

SN - 1831-4732

VL - 13

JO - E F S A Journal

JF - E F S A Journal

IS - 1

M1 - 3956

ER -