# L_2014232EN.01001601.xml

| 5.8.2014 | EN | Official Journal of the European Union | L 232/16 |
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5.8.2014

EN

Official Journal of the European Union

L 232/16

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COMMISSION IMPLEMENTING REGULATION (EU) No 849/2014

of 4 August 2014

concerning the authorisation of the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 as feed additives 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(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives. |
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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(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives.

| (2) | In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 were entered in the Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species. |
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(2)

In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 were entered in the Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of those preparations as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage 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, applications were submitted for the authorisation of those preparations as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage 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 6 March 2014 (2) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment.The Authority also concluded that the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 have the potential to improve the production of silage by increasing the lactic acid concentration and reduce dry matter losses. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods 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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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 6 March 2014 (2) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment.The Authority also concluded that the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 have the potential to improve the production of silage by increasing the lactic acid concentration and reduce dry matter losses. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex to this Regulation.

| (6) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, 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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(6)

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

| (7) | 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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(7)

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 preparations specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Transitional measures

The preparations specified in the Annex and feed containing them, which are produced and labelled before 25 February 2015 in accordance with the rules applicable before 25 August 2014 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3

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, 4 August 2014.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  EFSA Journal 2014; 12(3):3613; EFSA Journal 2014; 12(3):3611; EFSA Journal 2014; 12(3):3612.

2

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of fresh material |
| Category of technological additives. Functional group: silage additives |
| 1k21013 | — | Pediococcus acidilactici

  NCIMB 30005 | Additive composition

  Preparation of Pediococcus acidilactici NCIMB 30005 containing a minimum of 1 × 107 CFU/g of additive.

  Characterisation of the active substance

  Viable cells of Pediococcus acidilactici NCIMB 30005.

  Analytical method
   (1)

  Enumeration in the feed additive: spread plate method using MRS agar (EN 15786).
  Identification: Pulsed Field Gel Electrophoresis (PFGE). | All animal species | — | — | — | 1. | In the directions for use of the additive and premixture, indicate the storage conditions. |

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

CFU/kg of fresh material

Category of technological additives. Functional group: silage additives

1k21013

—

Pediococcus acidilactici

NCIMB 30005

Additive composition

Preparation of Pediococcus acidilactici NCIMB 30005 containing a minimum of 1 × 107 CFU/g of additive.

Characterisation of the active substance

Viable cells of Pediococcus acidilactici NCIMB 30005.

Analytical method
   (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15786).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage conditions.

| 2. | Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material. |
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2.

Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material.

| 3. | For safety: it is recommended to use breathing protection, eye protection and gloves during handling. |
| --- | --- |

3.

For safety: it is recommended to use breathing protection, eye protection and gloves during handling.

25 August 2024

1k20748

—

Lactobacillus paracasei

NCIMB 30151

Additive composition

Preparation of Lactobacillus paracasei NCIMB 30151 containing a minimum of 1 × 107 CFU/g of additive.

Characterisation of the active substance

Viable cells of Lactobacillus paracasei NCIMB 30151.

Analytical method
   (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

| 1. | In the directions for use of the additive and premixture, indicate the storage conditions. |
| --- | --- |

1.

In the directions for use of the additive and premixture, indicate the storage conditions.

| 2. | Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material. |
| --- | --- |

2.

Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material.

| 3. | For safety: it is recommended to use breathing protection, eye protection and gloves during handling. |
| --- | --- |

3.

For safety: it is recommended to use breathing protection, eye protection and gloves during handling.

1k20749

—

Lactobacillus plantarum

DSMZ 16627

Additive composition

Preparation of Lactobacillus plantarum DSMZ 16627 containing a minimum of 1 × 107 CFU/g of additive.

Characterisation of the active substance

Viable cells of Lactobacillus plantarum DSMZ 16627

Analytical method
   (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

—

—

—

| 1. | In the directions for use of the additive and premixture, indicate the storage conditions. |
| --- | --- |

1.

In the directions for use of the additive and premixture, indicate the storage conditions.

| 2. | Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material. |
| --- | --- |

2.

Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material.

| 3. | For Safety: it is recommended to use breathing protection, eye protection and gloves during handling. |
| --- | --- |

3.

For Safety: it is recommended to use breathing protection, eye protection and gloves during handling.

25 August 2024

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(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: www.irmm.jrc.be/eurl-feed-additives

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