Commission Implementing Regulation (EU) 2015/724 of 5 May 2015 concerning the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate as feed additives for all animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2015/724@2015-05-05/en
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, 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 such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC.
(2) Vitamin A was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of vitamin A in the form of retinyl acetate, retinyl palmitate and retinyl propionate as feed additives and their preparations for all animal species and, in accordance with Article 7 of that Regulation, for a new use in water for drinking. The applicant requested these additives to be classified in the additive category nutritional additives. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (the Authority) concluded in its opinion of 12 December 2012 that, under the proposed conditions of use in feed, retinyl acetate, retinyl palmitate and retinyl propionate do not have an adverse effects on animal health, human health or the environment.
(5) The Authority further concluded that retinyl acetate, retinyl palmitate and retinyl propionate are effective sources of vitamin A and that no safety concerns would arise for users. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of retinyl acetate, retinyl palmitate and retinyl propionate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied except for water for drinking. Accordingly, the use of these substances should be authorised in feed as specified in the Annex to this Regulation. Maximum contents should be set for vitamin A irrespective of its form. Vitamin A should not be administered directly via water for drinking because an additional route of administration would increase the risk for consumers. Therefore, the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate as nutritional additives belonging to the functional group vitamins, pro-vitamins and chemically well-defined substances having similar effect should be denied as regards their use in water. This prohibition does not apply to those additives within a compound feed subsequently administered via water.
(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(8) 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 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
Authorisation of retinyl acetate, retinyl palmitate and retinyl propionate, as additives belonging to the additive category nutritional additives and to the functional group vitamins, pro-vitamins and chemically well-defined substances having similar effect, is denied for use in water.
Article 3
The substances specified in the Annex and premixtures containing these substances, which are produced and labelled 26 November 2015 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted. Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2016 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2017 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 4
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, 5 May 2015. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX 1.2.3.4.5.6.1.2.3.4.5.6.1.2.3.4.5.6.
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 IU of vitamin A/kg of complete feedingstuff with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, provitamins and chemically well defined substances having a similar effect 3a672a — Retinyl acetate, or Vitamin A Piglets (suckling and weaned) — — 16000 The additive shall be incorporated into the feed via a premixture. Retinyl acetate may be placed on the market and used as an additive consisting of a preparation. For the content, as set out on the label the following equivalency shall be used: 1IU = 0,344 μg retinyl acetate. The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories. In the directions for use of the additive and premixtures indicate storage and stability conditions. For safety: breathing protection, safety glasses and gloves shall be worn during handling. 26 May 2025 Pigs for fattening — — 6500 Sows — — 12000 Other pigs — — — Chickens and minor poultry species ≤ 14 days — 20000 > 14 days — 10000 Turkeys ≤ 28 days — 20000 > 28 days — 10000 Other poultry — — 10000 Dairy cows and cows for reproduction — 9000 Calves for rearing 4 months — 16000 Other calves and cows — — 25000 Lambs and kids for rearing ≤ 2 months — 16000 > 2 months — — Cattle, sheep and goats for fattening — — 10000 Other bovines, sheep and goats — — — Mammals — — Milk replacers only: 25000 Other animal species — — — 3a672b Retinyl palmitate or Vitamin A Piglets (suckling and weaned) — — 16000 The additive shall be incorporated into the feed via a premixture. Retinyl palmitate may be placed on the market and used as an additive consisting of a preparation. For the content, as set out on the label, the following equivalency shall be used: 1IU = 0,5458 μg retinyl palmitate. The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories. In the directions for use of the additive and premixtures indicate storage and stability conditions. For safety: breathing protection, safety glasses and gloves shall be worn during handling. 26 May 2025 Pigs for fattening — — 6500 Sows — — 12000 Other pigs — — — Chickens and minor poultry species ≤ 14 days — 20000 > 14 days — 10000 Turkeys ≤ 28 days — 20000 > 28 days — 10000 Other poultry — — 10000 Dairy cows and cows for reproduction — — 9000 Calves for rearing 4 months — 16000 Other calves and cows — — 25000 Lambs and kids for rearing ≤ 2 months — 16000 > 2 months — — Cattle, sheep and goats for fattening — — 10000 Other bovines, sheep and goats — — — Mammals — — Milk replacers only: 25000 Other animal species — — — 3a672c Retinyl propionate or Vitamin A Piglets (suckling and weaned) — — 16000 The additive shall be incorporated into the feed via a premixture. Retinyl propionate may be placed on the market and used as an additive consisting of a preparation. For the content, as set out on the label, the following equivalency shall be used: 1IU = 0,3585 μg retinyl propionate. The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories. In the directions for use of the additive and premixtures indicate storage and stability conditions For safety: breathing protection, safety glasses and gloves shall be worn during handling. 26 May 2025 Pigs for fattening — — 6500 Sows — — 12000 Other pigs — — — Chickens and minor poultry species ≤ 14 days — 20000 > 14 days — 10000 Turkeys ≤ 28 days — 20000 > 28 days — 10000 Other poultry — — 10000 Dairy cows and cows for reproduction — — 9000 Calves for rearing 4 months — 16000 Other calves or cows — — 25000 Lambs and kids for rearing ≤ 2 months — 16000 > 2 months — — Cattle, sheep and goats for fattening — — 10000 Other bovines, sheep and goats — — — Mammals — — Milk replacers only: 25000 Other animal species — — —
ANNEX Additive composition
Retinyl acetate Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg
Characterisation of the active substance
Retinyl acetate C22H32O2 CAS No: 127-47-9 Retinyl acetate, solid form, produced by chemical synthesis. Purity criteria: min. 95 % (min. 2,76 MIU/g).
Methods of analysis
For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217). For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Commission Regulation (EC) No 152/2009.
ANNEX 1.2.3.4.5.6. Additive composition
Retinyl palmitate Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive
Characterisation of the active substance
Retinyl palmitate C36H60O2 Cas No:79-81-2 Retinyl palmitate, solid and liquid forms, produced by chemical synthesis: min. 90 % or 1,64 MIU/g.
Methods of analysis
For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217). For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Regulation (EC) No 152/2009.
ANNEX 1.2.3.4.5.6.1.2.3.4.5.6. Additive composition
Retinyl propionate Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive
Characterisation of the active substance
Retinyl propionate C23H34O2 Cas No.:7069-42-3 Retinyl propionate, liquid form, produced by chemical synthesis: min. 95 % or 2,64 MIU/g
Methods of analysis
For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217). For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Regulation (EC) No 152/2009.