Commission Implementing Regulation (EU) 2024/1068 of 12 April 2024 concerning the authorisation of a preparation of rosemary extract as a feed additive for cats and dogs

Official Journal EN of the European Union L series 2024/1068 15.4.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1068 of 12 April 2024 concerning the authorisation of a preparation of rosemary extract as a feed additive for cats and dogs (Text with EEA relevance) 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 2003on additives for use in animal nutrition(1), and 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 an authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of rosemary extract obtained from dried leaves of Rosmarinus officinalis L., by acetone or ethanol extraction. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of a preparation of rosemary extract as a feed additive for cats and dogs, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘antioxidants’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 November 2021(2)that, under the proposed conditions of use, the preparation of rosemary extract obtained from dried leaves of Rosmarinus officinalis L., by acetone or ethanol extraction, is safe up to the maximum use levels of 300 mg/kg and 50 mg/kg complete feed for dogs and cats, respectively (that corresponds to a concentration of carnosic acid of 34 and 5 mg/ kg respectively). It also concluded that the preparation should be considered as irritant to skin and eyes, but it could not conclude on its potential to be skin sensitiser. It considered that exposure through inhalation is unlikely. Since rosemary extract is used as a food additive, and its function in feed would be essentially the same as that in food, the Authority concluded that no further demonstration of efficacy is considered necessary. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) In view of the above, the Commission considers that the preparation of rosemary extract satisfies the conditions

provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) EFSA Journal 2022;20(1):6978.

ELI: http://data.europa.eu/eli/reg_impl/2024/1068/oj 1/4EN OJ L, 15.4.2024

HAS ADOPTED THIS REGULATION:

Article 1 The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘antioxidants’, 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.

Done at Brussels, 12 April 2024.

For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/1068/ojANNEX Minimum Maximum Identifica- content content tion Species or Composition, chemical formula, End of period of number of Additive category Maximum age Other provisions description, analytical method mg carnosic acid/kg of complete authorisation the feed of animal feed with a moisture content of additive 12 %

Category: technological additives. Functional group: antioxidants 1b392 Rosemary extract Additive composition Cats 5 1. In the directions for use of 5 May 2034 Preparation of rosemary extract from the additive and premix­ dried leaves of Rosmarinus officinalis Dogs 34 tures, the storage condi­ with carnosic acid 9-12 %, sum of car­ tions and stability to heat nosic acid and carnosol ≥ 10 % treatment shall be indi­ cated.

Liquid form 2. The simultaneous use of different sources of carno­ Extract is obtained through acetone or sic acid shall not result in ethanol extraction methods. exceeding the permitted maximum level of that Residual solvents (acetone or ethanol) substance in complete fee­ ≤ 250 mg/kg dingstuffs established for Camphor ≤ 150 mg/kg each relevant species.

3. For users of the additive Characterisation of the active substances and premixtures, feed Carnosic acid C H O 20 28 4 business operators shall CAS number 3650-09-7 establish operational pro­ Carnosol C H O cedures and organisational 20 26 4 CAS number 5957-80-2 measures to address po­ tential risks resulting from Sum of carnosic acid and carnosol in their use. Where those risks

the extract: cannot be eliminated by ≥ 90 % w/w of the total phenolic diter­ such procedures and mea­ penes of the extract; ≥ 15 % w/w of sures, the additive and total volatiles premixtures shall be used with personal skin, eye and breathing protective equipment.

ELI:

http://data.europa.eu/eli/reg_impl/2024/1068/oj 3/4 OJ L,

15.4.2024 ENAnalytical method(1) For the quantification of carnosic acid

and carnosol in the feed additive: — High performance liquid chroma­ tography with spectrophoto­ metric detection (HPLC-UV) For the quantification of carnosic acid

in compound feed: — Gas chromatography with flame ionisation detection (GC-FID)

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en 4/4

ELI:

http://data.europa.eu/eli/reg_impl/2024/1068/oj EN OJ L,

15.4.2024