欧盟授权维生素D3为所有物种的饲料添加剂

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Cholecalciferol was authorised without a time limit by Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, three applications were submitted for the re-evaluation of cholecalciferol as a feed additive for all animal species and, in accordance with Article 7 of that Regulation, for the use in water for drinking. The applicants requested that additive to be classified in the additive category ‘nutritional additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 13 November 2012 (3), 20 June 2013 (4), 30 January 2014 (5) and 25 January 2017 (6) that, under the proposed conditions of use in feed, cholecalciferol does not have adverse effects on animal health, human health or the environment. The Authority further concluded that cholecalciferol is an effective source of vitamin D3.

(5)

The Authority concluded in its opinions that for some formulations of vitamin D3 there is a potential for workers to be exposed to high levels of vitamin D3 by inhalation. Inhaled vitamin D3 is highly toxic and exposure to dust is harmful. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of cholecalciferol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied except for water for drinking. Accordingly, the use of that substance should be authorised in feed as specified in the Annex to this Regulation. Maximum contents should be set for cholecalciferol. Cholecalciferol should not be administered directly via water for drinking because an additional route of administration would increase the risk for consumers and animals. Therefore, the authorisation of cholecalciferol as nutritional additive belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ should be denied as regards their use in water. This prohibition does not apply to this substance when is used within compound feeds which are subsequently administered via water.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of cholecalciferol it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

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

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

IU or mg of cholecalciferol (1)/kg of complete feedingstuff with a moisture content of 12 %.

Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect

3a671

—

‘Cholecalciferol’ or ‘Vitamin D3’

Additive composition

Cholecalciferol.

Characterisation of the active substance

Cholecalciferol

C27H44O

CAS number: 67-97-0

Cholecalciferol solid and resin form, produced by chemical synthesis.

Purity criteria:

Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol.

Method of analysis  (2)

Pigs

2 000 IU

0,05 mg

11 September 2027

Milk replacers for piglets

10 000 IU

0,25 mg

Bovines

4 000 IU

0,1 mg

Milk replacers for calves

10 000 IU

0,25 mg

Ovines

4 000 IU

0,1 mg

Chickens for fattening

5 000 IU

0,125 mg

Turkeys

5 000 IU

0,125 mg

Other poultry

3 200 IU

0,080 mg

Equines

4 000 IU

0,1 mg

Fish species

3 000 IU

0,075 mg

Other species

2 000 IU

0,05 mg