LegalizeCommission Implementing Regulation (EU) 2021/2097 of 29 November 2021 concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of the authorisation Novus Europe NV) (Text with EEA relevance)
Article 1
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical 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.
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 |
|---|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feed with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: other zootechnical additives (improving zootechnical performance). | |||||||||
| 4d14 | Novus Europe NV | Preparation of benzoic acid, calcium formate and fumaric acid | Additive composition: Preparation of benzoic acid, calcium formate and fumaric acid having a minimum content of: benzoic acid: 42,5-50 %, calcium formate: 2,5-3,5 %, fumaric acid: 0,8-1,2 %; Granulated form | Turkeys for fattening Turkeys reared for breeding | - | 500 | 1 000 | 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. When the additive is used with other sources of formates, formic acid, fumaric acid and fumarates, the following overall contents in complete feedingstuffs shall not be exceeded: — 10 000 mg/kg of formic acid and — 20 000 mg/kg of fumaric acid. 3. 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 breathing protection. | 20 December 2031 |
| Characterisation of the active substance: Benzoic acid (purity ≥ 99,0 %); CAS number: 65-85-0; Chemical formula C7H6O2 Calcium formate: CAS number 544-17-2; Chemical formula C2H2O4Ca; Fumaric acid (purity ≥ 99,5 %): CAS number 110-17-8; Chemical formula C4H4O4. | |||||||||
| Analytical method (1) For the determination of benzoic acid, calcium formate and fumaric acid in the feed additive: — high performance liquid chromatography with UV detection (HPLC-UV); For the determination of total calcium in the feed additive: — atomic absorption spectrometry (AAS) – EN ISO 6869; or — inductively coupled plasma atomic emission spectrometry (ICP-AES) – EN 15510; For the determination of benzoic acid in premixtures and feedingstuffs: — high performance liquid chromatography with UV detection (HPLC-UV); For the determination of calcium formate and fumaric acid in premixtures: — ion-exclusion high performance liquid chromatography with UV or refractive index detection (HPLC-UV/RI). | |||||||||
| (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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