# L_2019139EN.01000401.xml

| 27.5.2019 | EN | Official Journal of the European Union | L 139/4 |
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27.5.2019

EN

Official Journal of the European Union

L 139/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/849

of 24 May 2019

amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids

(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 13(2) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2017/1492 (2) authorises cholecalciferol (vitamin D3) as nutritional additive for all animal species. In that Regulation, the maximum authorised content of vitamin D3 for fish is 3 000 IU/kg of complete feedingstuff. |
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(1)

Commission Implementing Regulation (EU) 2017/1492 (2) authorises cholecalciferol (vitamin D3) as nutritional additive for all animal species. In that Regulation, the maximum authorised content of vitamin D3 for fish is 3 000 IU/kg of complete feedingstuff.

| (2) | The Norwegian Food Safety Authority (NFSA) submitted studies on the safety of vitamin D3 for fish and consumers at substantially higher levels (60 000 IU/kg of complete feedingstuff) than the maximum authorised content. |
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(2)

The Norwegian Food Safety Authority (NFSA) submitted studies on the safety of vitamin D3 for fish and consumers at substantially higher levels (60 000 IU/kg of complete feedingstuff) than the maximum authorised content.

| (3) | For control purposes the results of calculation of tolerance levels can lead to a discrepancy in values between the two units (mg or IU). For this reason, the levels in the authorisation should be established only in International Units. |
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(3)

For control purposes the results of calculation of tolerance levels can lead to a discrepancy in values between the two units (mg or IU). For this reason, the levels in the authorisation should be established only in International Units.

| (4) | On the basis of the data submitted by the NFSA, the European Food Safety Authority concluded in its opinions of 25 January 2017 (3) and 29 November 2018 (4) that a total level of 60 000 IU of vitamin D3 per kg of complete feedingstuff is safe for consumers and the environment. The European Food Safety Authority also concluded that the levels proposed were safe for salmonids. For other fish, no sufficient data were available to conclude on the safety for a total level of 60 000 IU vitamin D3/kg of complete feedingstuff. Consequently, the authorisation should be restricted to salmonids. It also concluded in the opinion of 13 November 2012 (5) that vitamin D3 is not an irritant to skin and eyes and is not a skin sensitiser. 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. Exposure to dust is harmful to persons handling the additive. As the levels of vitamin D3 have been increased this may have implications for user safety, therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. |
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(4)

On the basis of the data submitted by the NFSA, the European Food Safety Authority concluded in its opinions of 25 January 2017 (3) and 29 November 2018 (4) that a total level of 60 000 IU of vitamin D3 per kg of complete feedingstuff is safe for consumers and the environment. The European Food Safety Authority also concluded that the levels proposed were safe for salmonids. For other fish, no sufficient data were available to conclude on the safety for a total level of 60 000 IU vitamin D3/kg of complete feedingstuff. Consequently, the authorisation should be restricted to salmonids. It also concluded in the opinion of 13 November 2012 (5) that vitamin D3 is not an irritant to skin and eyes and is not a skin sensitiser. 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. Exposure to dust is harmful to persons handling the additive. As the levels of vitamin D3 have been increased this may have implications for user safety, therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

| (5) | The Annex to Implementing Regulation (EU) 2017/1492 should therefore be amended accordingly. |
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(5)

The Annex to Implementing Regulation (EU) 2017/1492 should therefore be amended accordingly.

| (6) | 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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(6)

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

The Annex to Implementing Regulation (EU) 2017/1492 is replaced by the text set out in the Annex to this Regulation.

Article 2

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, 24 May 2019.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Commission Implementing Regulation (EU) 2017/1492 of 21 August 2017 concerning the authorisation of cholecalciferol as a feed additive for all animal species (OJ L 216, 22.8.2017, p. 19).

2

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

3

EFSA Journal

(4)  
  EFSA Journal 2019;17(1):5540.

4

EFSA Journal

(5)  
  EFSA Journal 2012;10(12):2968

5

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 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 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

| 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:






  — | ≤ 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:

—

≤ 5 000 IU of vitamin D3 for chickens for fattening and turkeys for fattening,

| — | ≤ 3 200 IU for other poultry, |
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—

≤ 3 200 IU for other poultry,

| — | ≤ 2 000 IU for pigs. |
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—

≤ 2 000 IU 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

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—

10 000 IU

Bovines

—

—

4 000 IU

Milk replacers for calves

—

—

10 000 IU

Ovines

—

—

4 000 IU

Chickens for fattening

—

—

5 000 IU

Turkeys

—

—

5 000 IU

Other poultry

—

—

3 200 IU

Equines

—

—

4 000 IU

Salmonids

—

—

60 000 IU

Other fish species

—

—

3 000 IU

Other animal species

—

—

2 000 IU

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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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