Commission Implementing Regulation (EU) 2022/1419 of 22 August 2022 concerning the authorisation of buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1419
• Articles: 4

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 12 March 2023 in accordance with the rules applicable before 12 September 2022 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 12 September 2023 in accordance with the rules applicable before 12 September 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 12 September 2024 in accordance with the rules applicable before 12 September 2022 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 3 Entry into force

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 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 additive/kg of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

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Buchu leaf essential oil

Additive composition

Buchu leaf essential oil obtained from the leaves of Agathosma betulina (P.J. Bergius) Pillans

Liquid form

Methyleugenol ≤ 0,17 %

Characterisation of the active substance

Buchu leaf essential oil produced by steam distillation from the leaves of Agathosma betulina (P.J. Bergius) Pillans as defined by the Council of Europe  ( 1 ) .

d,l-Isomenthone: 19–27 %

d-Limonene: 19–26 %

2-Hydroxypiperitone (or diosphenol): 8–17 %

p-Menthan-3-one: 5–12 %

Pulegone: 1,5–8 %

CAS number: 68650-46-4

CoE number: 85c

FEMA number: 2169

Analytical method

( 2 )

For the determination of d-limonene and d,l-isomenthone (phytochemical markers) in the feed additive (buchu leave essential oil):

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gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 11024)

All animal species except cats

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1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

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

3.

Mixture with other additives containing methyleugenol is not permitted.

4.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

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chickens for fattening and other minor poultry species for fattening: 0,1 mg;

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laying hens and other minor poultry species for laying and breeding purposes, turkeys for fattening and rabbits: 0,15 mg;

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piglets of all Suidae species: 0,20 mg;

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all Suidae for fattening: 0,25 mg;

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sows and dairy ruminants: 0,30 mg;

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ruminants for fattening and horses: 0,45 mg;

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calves (milk replacer), dogs, fish and ornamental fish: 0,5 mg;

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other species, except cats: 0,1 mg.’

5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 4.

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

12.9.2032

Cats

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0,2

( 1 )   Natural sources of flavourings – Report No 2 (2007).

( 2 )   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