LegalizeCommission Implementing Regulation (EU) No 669/2014 of 18 June 2014 concerning the authorisation of calcium D-pantothenate and D-panthenol as feed additives for all animal species Text with EEA relevance
Article 1
The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.
Article 2
The substances specified in the Annex and feed containing those substances, which are produced and labelled before 9 January 2015 in accordance with the rules applicable before 9 July 2014 may continue to be placed on the market and used until the existing stocks are exhausted.
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.
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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | mg/kg of complete feedingstuff with a moisture content of 12 % or mg/l of water | mg/kg of complete feedingstuff with a moisture content of 12 % or mg/l of water | Other provisions | End of period of authorisation | ||||||
| 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 | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect |
| 3a841 | — | Calcium D-pantothenate | Additive composition Calcium D-pantothenate. Characterisation of the active substance Calcium D-pantothenate Ca[C9H16NO5]2 CAS No: 137-08-6 Calcium D-pantothenate, solid form, produced by chemical synthesis. Purity criteria: 1. Min. 98 % (on dry basis) 2. Max. 0,5 % 3-aminopropionic acid. Method of Analysis [^E0004] — For the determination of Calcium D-pantothenate in the feed additive: potentiometric titration with perchloric acid and identification by specific optical rotation (European Pharmacopoeia monograph 0470). — For the determination of Calcium D-pantothenate in premixtures and feedingstuffs: Reverse Phase High-Performance Liquid Chromatography coupled to a single-quadrupole mass selective detector (RP-HPLC-MS). | All animal species. | — | — | — | Other provisions | End of period of authorisation | 1. May be used also via water for drinking. 2. In the directions for use of the additive and premixture, indicate the storage and stability conditions. 3. For safety: breathing protection, safety glasses and gloves should be worn during handling. | 9 July 2024 | ||||
| 3a842 | — | D-Panthenol | Additive composition D-Panthenol Characterisation of the active substance. D-Panthenol C9H19NO4 CAS No: 81-13-0 D-Panthenol, liquid form, produced by chemical synthesis Purity criteria: 1. Min. 98 % on anhydrous basis (water < 1 %) 2. Max. 0,5 % 3-aminopropanol. Method of Analysis [^E0004] — For the determination of D-panthenol in the feed additive: titration with perchloric acid and potassium hydrogen phthalate and identification by specific optical rotation and infrared spectroscopy (European Pharmacopoeia monograph 0761). — For the determination of D-panthenol in water: Reverse Phase High-Performance Liquid Chromatography, coupled to UV detector (RP-HPLC). | All animal species | — | — | 1. To be used only via water for drinking. 2. In the directions for use of the additive indicate the storage conditions. 3. For safety: breathing protection, safety glasses and gloves should be worn during handling. | 9 July 2024 |
Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
OJ L 268, 18.10.2003, p. 29.
OJ L 270, 14.12.1970, p. 1.
EFSA Journal 2011; 9(11):2409 and EFSA Journal 2011; 9(11):2410.
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