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Document 02014R0669-20140709

Consolidated text: Commission 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)

ELI: http://data.europa.eu/eli/reg_impl/2014/669/2014-07-09

02014R0669 — EN — 09.07.2014 — 000.001


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COMMISSION 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)

(OJ L 179 19.6.2014, p. 62)


Corrected by:

►C1

Corrigendum, OJ L 281, 25.9.2014, p.  9 (669/2014)




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COMMISSION 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

mg/kg of complete feedingstuff with a moisture content of 12 % or mg/l of water

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 (1)

— 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.

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.

►C1  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 (1)

— 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.

►C1  9 July 2024 ◄

(1)   

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



( 1 )  OJ L 268, 18.10.2003, p. 29.

( 2 )  OJ L 270, 14.12.1970, p. 1.

( 3 EFSA Journal 2011; 9(11):2409 and EFSA Journal 2011; 9(11):2410.

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