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

• CELEX: Implementing Regulation (EU) 2024/1068
• Articles: 3

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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed additive

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 carnosic acid/kg of complete feed with a moisture content of 12 %

Category: technological additives. Functional group: antioxidants

1b392

Rosemary extract

Additive composition

Preparation of rosemary extract from dried leaves of Rosmarinus officinalis with carnosic acid 9-12 %, sum of carnosic acid and carnosol ≥ 10 %

Liquid form

Extract is obtained through acetone or ethanol extraction methods.

Residual solvents (acetone or ethanol) ≤ 250 mg/kg

Camphor ≤ 150 mg/kg

Characterisation of the active substances

Carnosic acid C 20 H 28 O 4

CAS number 3650-09-7

Carnosol C 20 H 26 O 4

CAS number 5957-80-2

Sum of carnosic acid and carnosol in the extract:

≥ 90 % w/w of the total phenolic diterpenes of the extract; ≥ 15 % w/w of total volatiles

Analytical method

( 1 )

For the quantification of carnosic acid and carnosol in the feed additive:

—

High performance liquid chromatography with spectrophotometric detection (HPLC-UV)

For the quantification of carnosic acid in compound feed:

—

Gas chromatography with flame ionisation detection (GC-FID)

Cats

Dogs

5

34

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

The simultaneous use of different sources of carnosic acid shall not result in exceeding the permitted maximum level of that substance in complete feedingstuffs established for each relevant species.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

5 May 2034

( 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