Commission Implementing Regulation (EU) 2022/347 of 1 March 2022 concerning the authorisation of petitgrain bigarade essential oil as a feed additive for certain animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/347
• 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 an 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 22 September 2022 in accordance with the rules applicable before 22 March 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 22 March 2023 in accordance with the rules applicable before 22 March 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 22 March 2024 in accordance with the rules applicable before 22 March 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

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 active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives

Functional group: Flavouring compounds

2b136-eo

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Petitgrain bigarade essential oil

Additive composition

Petitgrain bigarade essential oil obtained from the leaves of Citrus aurantium L.

Liquid form

Characterisation of the active substance

Petitgrain bigarade essential oil obtained by steam distillation from the leaves of Citrus aurantium L. as defined by the Council of Europe  ( 1 ) .

Linalyl acetate: 40–72 %.

Linalool: 10–32 %.

α-Terpineol: 1–7 %.

d-Limonene: 1–6 %.

Geranyl acetate: 1,5–5,5 %.

Geraniol: 1–4 %.

CAS number: 8014-17-3

Einecs number: 283-881-6

FEMA number: 2855

CoE number: 136

Analytical method

( 2 )

For the quantification of the phytochemical markers Linalyl acetate and Linalool in the feed additive (petigrain bigarade oil) or in mixture of flavouring compounds:

—

gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 8901)

Chickens for fattening

Laying hens

Turkeys for fattening

Pigs for fattening

Piglets

Lactating sows

Calves

Dairy cows

Cattle for fattening

Sheep/Goats

Horses

Rabbits

Salmonids

Dogs

Cats

Ornamental fish

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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.

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 %:

—

Chickens for fattening: 10 mg.

—

Laying hens: 14 mg.

—

Turkeys for fattening: 13 mg.

—

Pigs for fattening: 20 mg.

—

Piglets: 17 mg.

—

Lactating sows: 25 mg.

—

Calves (milk replacer): 43 mg.

—

Cattle for fattening, sheep, goats and horses: 38 mg.

—

Dairy cows: 24 mg.

—

Rabbits: 15 mg.

—

Salmonids: 42 mg.

—

Dogs: 44 mg.

—

Cats: 8 mg.

—

Ornamental fish: 125 mg’.

4.

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 3.

5.

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.

22 March 2032

( 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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports