# L_2018260EN.01000301.xml

| 17.10.2018 | EN | Official Journal of the European Union | L 260/3 |
| --- | --- | --- | --- |

17.10.2018

EN

Official Journal of the European Union

L 260/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1550

of 16 October 2018

concerning the renewal of the authorisation of benzoic acid as a feed additive for weaned piglets and pigs for fattening and repealing Regulations (EC) No 1730/2006 and (EC) No 1138/2007 (holder of authorisation DSM Nutritional Products Ltd)

(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 and renewing such authorisation. |
| --- | --- |

(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 and renewing such authorisation.

| (2) | Benzoic acid was authorised for 10 years as a feed additive for weaned piglets by Commission Regulation (EC) No 1730/2006 (2), and for pigs for fattening by Commission Regulation (EC) No 1138/2007 (3). |
| --- | --- |

(2)

Benzoic acid was authorised for 10 years as a feed additive for weaned piglets by Commission Regulation (EC) No 1730/2006 (2), and for pigs for fattening by Commission Regulation (EC) No 1138/2007 (3).

| (3) | In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of those authorisations for the renewal of the authorisation of benzoic acid as a feed additive, both for weaned piglets and for pigs for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of those authorisations for the renewal of the authorisation of benzoic acid as a feed additive, both for weaned piglets and for pigs for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 November 2017 (4) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The assessment of benzoic acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 November 2017 (4) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The assessment of benzoic acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

| (5) | As a consequence of the renewal of the authorisation of benzoic acid as a feed additive under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 1730/2006 and (EC) No 1138/2007 should be repealed. |
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(5)

As a consequence of the renewal of the authorisation of benzoic acid as a feed additive under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 1730/2006 and (EC) No 1138/2007 should be repealed.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulations (EC) No 1730/2006 and (EC) No 1138/2007 are repealed.

Article 3

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, 16 October 2018.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Commission Regulation (EC) No 1730/2006 of 23 November 2006 concerning the authorisation of benzoic acid (VevoVitall) as a feed additive (OJ L 325, 24.11.2006, p. 9).

2

(3)  Commission Regulation (EC) No 1138/2007 of 1 October 2007 concerning the authorisation of a new use of benzoic acid (VevoVitall) as a feed additive (OJ L 256, 2.10.2007, p. 8).

3

(4)  
  EFSA Journal 2017;15(12):5093.

4

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 | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechical parameters: weight gain or feed gain ratio) |
| 4d210 | DSM Nutritional Products Ltd | Benzoic acid | Additive composition

  Benzoic acid (≥ 99,9 %)

  Characterisation of the active substance | Benzenecarboxylic acid, phenylcarboxylic acid, |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechical parameters: weight gain or feed gain ratio)

4d210

DSM Nutritional Products Ltd

Benzoic acid

Additive composition

Benzoic acid (≥ 99,9 %)

Characterisation of the active substance

Benzenecarboxylic acid, phenylcarboxylic acid,

| | C7H6O2 |
| --- | --- |

C7H6O2

| | CAS number 65-85-0 |
| --- | --- |

CAS number 65-85-0

Maximum level of the impurities:

| | Phthalic acid: ≤ 100 mg/kg |
| --- | --- |

Phthalic acid: ≤ 100 mg/kg

| | Biphenyl: ≤ 100 mg/kg |
| --- | --- |

Biphenyl: ≤ 100 mg/kg

Analytical method
   (1)

For the quantification of benzoic acid in the feed additive:

| — | titration with sodium hydroxide (European Pharmacopoeia monograph 0066) |
| --- | --- |

—

titration with sodium hydroxide (European Pharmacopoeia monograph 0066)

For the quantification of the benzoic acid in the premixtures and feedingstuffs:

| — | reversed phase liquid chromatography with UV detection (RP-HPLC/UV) – method based on ISO9231:2008 |
| --- | --- |

—

reversed phase liquid chromatography with UV detection (RP-HPLC/UV) – method based on ISO9231:2008

Additive composition

Benzoic acid (≥ 99,9 %)

Characterisation of the active substance

| | Benzenecarboxylic acid, phenylcarboxylic acid, |
| --- | --- |

Benzenecarboxylic acid, phenylcarboxylic acid,

| | C7H6O2 |
| --- | --- |

C7H6O2

| | CAS number 65-85-0 |
| --- | --- |

CAS number 65-85-0

Maximum level of the impurities:

| | Phthalic acid: ≤ 100 mg/kg |
| --- | --- |

Phthalic acid: ≤ 100 mg/kg

| | Biphenyl: ≤ 100 mg/kg |
| --- | --- |

Biphenyl: ≤ 100 mg/kg

Analytical method
   (1)

For the quantification of benzoic acid in the feed additive:

| — | titration with sodium hydroxide (European Pharmacopoeia monograph 0066 |
| --- | --- |

—

titration with sodium hydroxide (European Pharmacopoeia monograph 0066

For the quantification of the benzoic acid in the premixtures and feedingstuffs:

| — | reversed phase liquid chromatography with UV detection (RP-HPLC/UV) – method based on ISO9231:2008 |
| --- | --- |

—

reversed phase liquid chromatography with UV detection (RP-HPLC/UV) – method based on ISO9231:2008

Piglets (weaned)

—

5 000

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

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

| 2. | Recommended minimum dose: 5 000 mg/kg of complete feed. |
| --- | --- |

2.

Recommended minimum dose: 5 000 mg/kg of complete feed.

| 3. | The additive shall not be used with other sources of benzoic acid or benzoates. |
| --- | --- |

3.

The additive shall not be used with other sources of benzoic acid or benzoates.

| 4. | The directions of use shall be indicated:
  ‘Complementary feedingstuffs containing benzoic acid shall not be fed to weaned piglets or pig for fattening as such.
  Complementary feedingstuffs shall be thoroughly mixed with other feed materials of the daily ration’. |
| --- | --- |

4.

The directions of use shall be indicated:

‘Complementary feedingstuffs containing benzoic acid shall not be fed to weaned piglets or pig for fattening as such.

Complementary feedingstuffs shall be thoroughly mixed with other feed materials of the daily ration’.

| 5. | For use in weaned piglets up to 35 kg of body weight. |
| --- | --- |

5.

For use in weaned piglets up to 35 kg of body weight.

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their 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 eyes and skin protection |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their 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 eyes and skin protection

5 November 2028

Category of zootechnical additives. Functional group: other zootechnical additives (urinary pH decrease)

4d210

DSM Nutritional Products Ltd

Benzoic acid

Additive composition

Benzoic acid (≥ 99,9 %)

Characterisation of the active substance

| | Benzenecarboxylic acid, phenylcarboxylic acid, |
| --- | --- |

Benzenecarboxylic acid, phenylcarboxylic acid,

| | C7H6O2 |
| --- | --- |

C7H6O2

| | CAS number 65-85-0 |
| --- | --- |

CAS number 65-85-0

Maximum level of the impurities:

| | Phthalic acid: ≤ 100 mg/kg |
| --- | --- |

Phthalic acid: ≤ 100 mg/kg

| | Biphenyl: ≤ 100 mg/kg |
| --- | --- |

Biphenyl: ≤ 100 mg/kg

Analytical method
   (1)

For the quantification of benzoic acid in the feed additive:

| — | titration with sodium hydroxide (European Pharmacopoeia monograph 0066) |
| --- | --- |

—

titration with sodium hydroxide (European Pharmacopoeia monograph 0066)

For the quantification of the benzoic acid in the premixtures and feedingstuffs:

| — | reversed phase liquid chromatography with UV detection (RP-HPLC/UV) – method based on ISO9231:2008 |
| --- | --- |

—

reversed phase liquid chromatography with UV detection (RP-HPLC/UV) – method based on ISO9231:2008

Pigs for fattening

5 000

10 000

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

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

| 2. | The additive shall not be used with other sources of benzoic acid or benzoates. |
| --- | --- |

2.

The additive shall not be used with other sources of benzoic acid or benzoates.

| 3. | The directions of use shall be indicated:
  ‘Complementary feedingstuffs containing benzoic acid shall not be fed to weaned piglets or pig for fattening as such.
  Complementary feedingstuffs shall be thoroughly mixed with other feed materials of the daily ration’. |
| --- | --- |

3.

The directions of use shall be indicated:

‘Complementary feedingstuffs containing benzoic acid shall not be fed to weaned piglets or pig for fattening as such.

Complementary feedingstuffs shall be thoroughly mixed with other feed materials of the daily ration’.

| 4. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their 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 eyes and skin protection. |
| --- | --- |

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their 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 eyes and skin protection.

5 November 2028

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(1)  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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