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.)

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Regulations (EC) No 1730/2006 and (EC) No 1138/2007 are repealed.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

ANNEX

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,
C 7 H 6 O 2
CAS number 65-85-0
Maximum level of the impurities:
Phthalic acid: ≤ 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)
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
Additive composition
Benzoic acid (≥ 99,9 %)
Characterisation of the active substance
Benzenecarboxylic acid, phenylcarboxylic acid,
C 7 H 6 O 2
CAS number 65-85-0
Maximum level of the impurities:
Phthalic acid: ≤ 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
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
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.
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.
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.
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,
C 7 H 6 O 2
CAS number 65-85-0
Maximum level of the impurities:
Phthalic acid: ≤ 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)
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
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.
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’.
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
( 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

Schedules & Appendices

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