Commission Implementing Regulation (EU) 2024/806 of 7 March 2024 concerning the authorisation of pine tincture from Pinus sylvestris L. as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2024/806
• 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 that substance, which are produced and labelled before 28 September 2024 in accordance with the rules applicable before 28 March 2024 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 specified in the Annex, which are produced and labelled before 28 March 2025 in accordance with the rules applicable before 28 March 2024 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 specified in the Annex, which are produced and labelled before 28 March 2026 in accordance with the rules applicable before 28 March 2024 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 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 active substance/kg of complete feed with a moisture content of 12 %

Category: sensory additives. Functional group: flavouring compounds

2b2816792-t

Pine tincture

Additive composition

Pine tincture from the buds of Pinus sylvestris L.

Liquid form

Characterisation of the active substance

Dry matter content: 1,9-2,5 %

Pine tincture from the buds of Pinus sylvestris L. by extraction with a water/ethanol mixture as defined by the Council of Europe  ( 1 ) .

EC number: 281-679-2  ( 2 )

Specifications

—

Polyphenols. 0,070–0,102 %

—

Phenolic acids: 0–0,038 %

—

Rutin: 0-0,001 %

—

Ferulic acid: 0,0003–0,0006 %

—

α-Terpineol: 0,00013-0,00025 %

Analytical method

( 3 )

For the characterisation of the feed additive: spectrophotometry for the determination of total polyphenols: high performance thin-layer chromatography (HPTLC) for the determination of total phenolic acids.

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 the 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 %: 50 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 the 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 breathing, eye and skin protective equipment.

28 March 2034

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

( 2 )   EC number covering Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Pinus sylvestris, Pinaceae . Source : ECHA Database.

( 3 )   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.