# L_2017216EN.01001901.xml

| 22.8.2017 | EN | Official Journal of the European Union | L 216/19 |
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22.8.2017

EN

Official Journal of the European Union

L 216/19

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1492

of 21 August 2017

concerning the authorisation of cholecalciferol as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (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). |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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, |
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(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, provitamins and chemically well-defined substances having similar effect’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Denial

Authorisation of cholecalciferol, as an additive belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, provitamins and chemically well-defined substances having similar effect’, is denied for its use in water for drinking.

Article 3

Transitional Measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 11 March 2018 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 11 September 2018 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 11 September 2019 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 4

Entry into Force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 August 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2012;10(12):2968.

3

EFSA Journal

(4)  
  EFSA Journal 2013;11(7):3289.

4

EFSA Journal

(5)  
  EFSA Journal 2014;12(2):3568.

5

EFSA Journal

(6)  
  EFSA Journal 2017;15(3):4713.

6

EFSA Journal

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ANNEX

| 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)







  — | For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) — European Pharmacopoeia method 01/2008:0574,0575,0598. |

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)

—

For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) — European Pharmacopoeia method 01/2008:0574,0575,0598.

| — | For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)- VDLUFA 1997, Methodenbuch, Method 13.8.1. |
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—

For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)- VDLUFA 1997, Methodenbuch, Method 13.8.1.

| — | For the determination of vitamin D3 in feedingstuffs:






  — | High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)- VDLUFA 1997, Methodenbuch, Method 13.8.1; or |
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—

For the determination of vitamin D3 in feedingstuffs:

—

High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)- VDLUFA 1997, Methodenbuch, Method 13.8.1; or

| — | Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. |
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—

Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821.

| — | For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. |
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—

For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821.

Pigs

2 000 IU

0,05 mg

| 1. | Vitamin D3 may be placed on the market and used as an additive consisting of a preparation. |
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1.

Vitamin D3 may be placed on the market and used as an additive consisting of a preparation.

| 2. | The additive shall be incorporated into the feed in the form of a premixture. |
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2.

The additive shall be incorporated into the feed in the form of a premixture.

| 3. | In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. |
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3.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

| 4. | Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol per kg of complete feedingstuff:






  — | ≤ 0,125 mg (1) (equivalent to 5 000  IU of vitamin D3) for chickens for fattening and turkeys for fattening, |
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4.

Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol per kg of complete feedingstuff:

—

≤ 0,125 mg (1) (equivalent to 5 000  IU of vitamin D3) for chickens for fattening and turkeys for fattening,

| — | ≤ 0,080 mg for other poultry, |
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—

≤ 0,080 mg for other poultry,

| — | ≤ 0,050 mg for pigs. |
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—

≤ 0,050 mg for pigs.

| 5. | Simultaneous use with Vitamin D2 is not allowed. |
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5.

Simultaneous use with Vitamin D2 is not allowed.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the very hazardous effects of vitamin D3 by inhalation. Where the risks associated to those very hazardous effects cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
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6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the very hazardous effects of vitamin D3 by inhalation. Where the risks associated to those very hazardous effects cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

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

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(1)  40 IU cholecalciferol= 0,001 mg cholecalciferol.

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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