Commission Implementing Regulation (EU) 2022/1451 of 1 September 2022 concerning the authorisation of camphor white essential oil from Cinnamomum camphora (L.) J. Presl. and cinnamon tincture from Cinnamomum verum J. Presl. as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1451
• Articles: 4

Article 1 Authorisation

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

Article 2 Transitional measures

1.   The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 22 March 2023, in accordance with the rules applicable before 22 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 substances as specified in the Annex, which are produced and labelled before 22 September 2023, in accordance with the rules applicable before 22 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 substances as specified in the Annex, which are produced and labelled before 22 September 2024, in accordance with the rules applicable before 22 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

2b130-eo

Camphor white essential oil

Additive composition

Camphor white essential oil obtained from the whole plant Cinnamomum camphora (L.) J. Presl.

Camphor ≤ 0,1 %

Safrole ≤ 0,0002 %

Liquid form

Characterisation of the active substance

Camphor white essential oil obtained by steam distillation from the whole

plant Cinnamomum camphora (L.) J. Presl as defined by the Council of Europe  ( 1 ) .

1,8-Cineole: 27–43 %

d-Limonene (18–27 %)

1-Isopropyl-4-Methylbenzene (p-cymene): 6–15 %

α-Pinene (pin-2(3)-ene): 4–10 %

CAS number: 8008-51-3

Einecs number: 294-760-2

FEMA number: 2231

CoE number: 130

Analytical method

( 2 )

For the determination of 1,8-Cineole (phytochemical marker) in the feed additive:

—

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

All animal species except cats

-

-

-

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 camphor and safrole 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 %:

—

chickens for fattening and other minor poultry species for fattening: 28 mg;

—

Laying hens and other minor poultry species for laying and breeding purposes: 42 mg;

—

Turkeys for fattening: 37 mg;

—

Suidae , horses, rabbits, fish, ornamental fish and dogs: 30 mg;

—

Ruminants: 50 mg;

—

Other species except cats: 22 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.

22 September 2032

Cats

-

-

22

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

2b2289-t

Cinnamon tincture

Additive composition

Cinnamon tincture obtained from the bark of Cinnamomum verum J. Presl.

Methyleugenol ≤ 0,00001 %

Safrole ≤ 0,00002 %

Liquid form

Characterisation of the active substance

Cinnamon tincture obtained by extended extraction with water/ethanol mixture (3:1, v/v) from the bark of Cinnamomum verum J. Presl. as defined by the Council of Europe  ( 3 ) .

Cinnamaldehyde: ≤ 0,0012 %

FEMA number cinnamon: 2289

Analytical method

( 4 )

For the characterisation of the feed additive (cinnamon tincture):

—

gravimetry for the determination of dry matter and ash content;

—

spectrophotometry for the determination of total polyphenols and total flavonoids content;

—

high performance thin-layer chromatography (HPTLC) for the determination of cinnamaldehyde content.

All animal species

-

-

-

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 and safrole 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 %:

—

All animal species except horses: 50 mg;

—

Horses: 60 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.

22 September 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

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

( 4 )   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