欧盟更改富含亚精胺的小麦胚芽提取物（Triticum aestivum）的新资源食品的规格

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list 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 (2) establishing a Union list of authorised novel foods was adopted.

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

(4)

On 6 December 2017, the company TLL The Longevity Labs GmbH (‘the applicant’), informed the Commission in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) of its intention to place on the market spermidine-rich wheat germ extract (Triticum aestivum) as a novel food ingredient. Therefore, spermidine-rich wheat germ extract was included in the Union list of novel foods.

(5)

On 6 August 2019, the applicant made a request to the Commission to change the specifications of spermidine-rich wheat germ extract in accordance with Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to increase the level of cadaverine from the current < 0,1 μg/g to ≤ 16,0 μg/g.

(6)

The applicant justifies the request by indicating that the change is necessary in order to reflect the natural levels of up to ≤ 16,0 μg/g of cadaverine that are analytically detectable in the wheat germ of the Triticum aestivum plant. The currently authorised level of < 0,1 μg/g cadaverine in spermidine-rich wheat germ extract represents the limit of detection with the analytical method that the applicant had erroneously included in the initial notification as the specification limit for cadaverine, and which was subsequently included in the Union list specifications of this novel food.

(7)

Cadaverine is a diamine which together with histamine, tyramine, and putrescine belong to the class of the biogenic amines that are naturally formed as the result of bacterial metabolism of proteins.

(8)

The health risks of biogenic amines were evaluated by the European Food Safety Authority (‘the Authority’) in 2011 (4). In the scientific opinion, the Authority noted that analytical information and food consumption data from the Member States has shown that cadaverine is present in a number of foods (alcoholic beverages, condiments, fish and fish products, meats, dairy products, vegetables and vegetable products) at mean levels up to 184 mg/kg of food with the resulting intakes reaching up to 116,1 mg of cadaverine per day.

(9)

Considering that the proposed maximum levels of cadaverine in the novel food and the resulting intakes on the basis of the authorised conditions of use of the novel food will be at least three orders of magnitude lower than the levels of cadaverine that are ingested from a normal diet, the Commission considers that the proposed changes in the cadaverine levels in the specifications of the spermidine-rich wheat germ extract do not alter the safety considerations that supported the authorisation of this novel food, and that a safety evaluation of the current application by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. Therefore, it is appropriate to amend the specifications of the novel food spermidine-rich wheat germ extract at the level for cadaverine requested by the applicant.

(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,