(fra kommisjonsforordningen)

(1)    Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2)    Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470  has established a Union list of novel foods.
(3)    The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes partially defatted rapeseed powder from Brassica rapa L. and Brassica napus L. as an authorised novel food.
(4)    Commission Implementing Regulation (EU) 2021/120  authorised the placing on the market of partially defatted rapeseed powder from Brassica rapa L. and Brassica napus L. as a novel food to be used in a number of foods.
(5)    On 19 October 2023, the company Ferm-food ApS (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications of the novel food partially defatted rapeseed powder from Brassica rapa L. and Brassica napus L. The applicant requested to decrease the levels of proteins and lipids, and to increase the levels of total carbohydrates, total fibre, moisture and ash in the final powder. 
(6)    The applicant provided justification for its request to modify the specifications of the novel food that concerns a change of a number of composition parameters. The applicant indicated that the requested modifications of the specifications entail a wider definition of the characteristics/composition of the novel food and that these modifications would allow for fluctuations in the Union yield, oil mill production and pressing methods. The proposed changes would also allow for the use of Brassica rapa L. and Brassica napus L. from both winter and spring harvests and therefore that would increase the supply of raw materials and of the potential production of partially defatted rapeseed powder for food. In particular, the decrease of the lower level of protein from 33% to 28% would allow to expand the supply of raw material and the potential for transforming more rapeseed cakes for feed into foods. Considering that the market demands low-fat foods, decreasing the lower level of lipids from 14% to 10% would allow a more suitable rapeseed powder as a food ingredient. Furthermore, increasing the maximum level of moisture from less than 7% to less than 11% would allow for more efficient technologies, enabling a less energy-demanding drying or stabilisation process, which would reduce the overall carbon footprint of rapeseed cake refinement for foods. Moreover, as the specified peroxide limit remains unchanged, the risk of oxidation does not increase with the suggested increase in moisture. The applicant also justified its request indicating that the requested decrease of levels of proteins and lipids, and the increase of levels of total carbohydrates, total fibre, moisture and ash in the final powder do not affect the safety of the novel food.
(7)    In addition to the variability of the raw material, proposed modifications of the novel food specifications are result of changes in the production process. In the Fermfood ApS process, the already partially defatted rapeseed cake is purchased from the EU rapeseed oil producers, transported to the Fermfood ApS production site, and fermented with a mix of lactic acid bacteria. The process does not include washing, filtration, centrifuging or acidification steps as described in the scientific opinion of the Food Safety Authority  (‘the Authority’). The waste product of lactic acid bacteria fermentation is lactic acid. 
(8)    The Commission considers that the requested update of the Union list concerning the change of the specifications of partially defatted rapeseed powder from Brassica rapa L. and Brassica napus L. proposed by the applicant, is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. Changes in the production process, the variability of the raw material and changes of levels of proteins, lipids, total carbohydrates, total fibre, moisture and ash do not affect the safety of the novel food as assessed by the Authority and do not alter the conclusions of the Authority that supported the initial authorisation. 
(9)    The information provided in the application gives sufficient grounds to establish that the changes to the specifications of the novel food are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and they should be approved.
(10)    The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. requested to decrease the levels of proteins and lipids, and to increase the levels of total carbohydrates, total fibre, moisture and ash in the final powder. 
(6)    The applicant provided justification for its request to modify the specifications of the novel food that concerns a change of a number of composition parameters. The applicant indicated that the requested modifications of the specifications entail a wider definition of the characteristics/composition of the novel food and that these modifications would allow for fluctuations in the Union yield, oil mill production and pressing methods. The proposed changes would also allow for the use of Brassica rapa L. and Brassica napus L. from both winter and spring harvests and therefore that would increase the supply of raw materials and of the potential production of partially defatted rapeseed powder for food. In particular, the decrease of the lower level of protein from 33% to 28% would allow to expand the supply of raw material and the potential for transforming more rapeseed cakes for feed into foods. Considering that the market demands low-fat foods, decreasing the lower level of lipids from 14% to 10% would allow a more suitable rapeseed powder as a food ingredient. Furthermore, increasing the maximum level of moisture from less than 7% to less than 11% would allow for more efficient technologies, enabling a less energy-demanding drying or stabilisation process, which would reduce the overall carbon footprint of rapeseed cake refinement for foods. Moreover, as the specified peroxide limit remains unchanged, the risk of oxidation does not increase with the suggested increase in moisture. The applicant also justified its request indicating that the requested decrease of levels of proteins and lipids, and the increase of levels of total carbohydrates, total fibre, moisture and ash in the final powder do not affect the safety of the novel food.
(7)    In addition to the variability of the raw material, proposed modifications of the novel food specifications are result of changes in the production process. In the Fermfood ApS process, the already partially defatted rapeseed cake is purchased from the EU rapeseed oil producers, transported to the Fermfood ApS production site, and fermented with a mix of lactic acid bacteria. The process does not include washing, filtration, centrifuging or acidification steps as described in the scientific opinion of the Food Safety Authority  (‘the Authority’). The waste product of lactic acid bacteria fermentation is lactic acid. 
(8)    The Commission considers that the requested update of the Union list concerning the change of the specifications of partially defatted rapeseed powder from Brassica rapa L. and Brassica napus L. proposed by the applicant, is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. Changes in the production process, the variability of the raw material and changes of levels of proteins, lipids, total carbohydrates, total fibre, moisture and ash do not affect the safety of the novel food as assessed by the Authority and do not alter the conclusions of the Authority that supported the initial authorisation. 
(9)    The information provided in the application gives sufficient grounds to establish that the changes to the specifications of the novel food are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and they should be approved.
(10)    The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. 

(11)    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,