# L_2021068EN.01016701.xml

| 26.2.2021 | EN | Official Journal of the European Union | L 68/167 |
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26.2.2021

EN

Official Journal of the European Union

L 68/167

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/346

of 25 February 2021

concerning the authorisation of a preparation of Lactobacillus parafarraginis DSM 32962 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. |
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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.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Lactobacillus parafarraginis DSM 32962. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Lactobacillus parafarraginis DSM 32962. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of a preparation of Lactobacillus parafarraginis DSM 32962 as a feed additive for all animal species, to be classified in the additive category ‘technological additives’. |
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(3)

The application concerns the authorisation of a preparation of Lactobacillus parafarraginis DSM 32962 as a feed additive for all animal species, to be classified in the additive category ‘technological additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 July 2020 (2) that, under the proposed conditions of use, the preparation of Lactobacillus parafarraginis DSM 32962 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be considered a potential respiratory sensitiser, and that no conclusions could be drawn on the skin sensitisation potential of the additive. 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. The Authority also concluded that the preparation concerned has the potential to improve the aerobic stability of silage from forage material with a dry matter content ranging from 30-70 %. 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 additive 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 opinion of 1 July 2020 (2) that, under the proposed conditions of use, the preparation of Lactobacillus parafarraginis DSM 32962 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be considered a potential respiratory sensitiser, and that no conclusions could be drawn on the skin sensitisation potential of the additive. 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. The Authority also concluded that the preparation concerned has the potential to improve the aerobic stability of silage from forage material with a dry matter content ranging from 30-70 %. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparation of Lactobacillus parafarraginis DSM 32962 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised. |
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(5)

The assessment of the preparation of Lactobacillus parafarraginis DSM 32962 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised.

| (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 preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 25 February 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  
  EFSA Journal 2020;18(7):6201

2

EFSA Journal

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ANNEX

| Identification number of the additive | 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 |
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| CFU of additive/kg of fresh material |
| Category of technological additives. Functional group:
  silage additives |
| 1k20760 | Lactobacillus parafarraginis DSM 32962 | Additive composition:

  Preparation of Lactobacillus parafarraginis DSM 32962 containing a minimum of 5 × 1011 CFU/g additive.
  Solid form | All animal species | - | - | - | 1. | In the directions for use of the additive and premixtures, the storage conditions shall be indicated. |

Identification number of the additive

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 of additive/kg of fresh material

Category of technological additives. Functional group:
  silage additives

1k20760

Lactobacillus parafarraginis DSM 32962

Additive composition:

Preparation of Lactobacillus parafarraginis DSM 32962 containing a minimum of 5 × 1011 CFU/g additive.

Solid form

All animal species

-

-

-

1.

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

| 2. | Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg of easy and moderately difficult to ensile fresh material (1). |
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2.

Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg of easy and moderately difficult to ensile fresh material (1).

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks 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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3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks 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.

18.3.2031

Characterisation of the active substance:

Viable cells of Lactobacillus parafarraginis DSM 32962.

Analytical method
   (2)

| — | Identification: Pulsed Field Gel Electrophoresis (PFGE) |
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Identification: Pulsed Field Gel Electrophoresis (PFGE)

| — | Enumeration in the feed additive: Spread plate method on MRS agar (EN 15787) |
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Enumeration in the feed additive: Spread plate method on MRS agar (EN 15787)

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(1)  Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).

(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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