Commission Implementing Regulation (EU) 2022/1383 of 8 August 2022 concerning the authorisation of olibanum extract from Boswellia serrata Roxb.ex Colebr. as a feed additive for horses and dogs (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Transitional measures
1. The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 28 February 2023 in accordance with the rules applicable before 29 August 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 29 August 2023 in accordance with the rules applicable before 29 August 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 29 August 2024 in accordance with the rules applicable before 29 August 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.
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 .
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 2b2816-ex Olibanum extract Additive composition Dry extract of olibanum from Boswellia serrata Roxb. ex Colebr. Solid form Methyleugenol ≤ 0,009 % Estragole ≤ 0,028 % Characterisation of the active substance Dry extract of olibanum produced by extraction from the oleoresin of Boswellia serrata Roxb. ex Colebr. as defined by the Council of Europe ( 1 ) . Olibanum oil: FEMA number: 2816 Boswellic acids: ≥ 65 % 11-keto-β-boswellic acid (KBA): 2,53-3,86 % CAS number: 17019-92-0 3-O-acetyl-11-keto β-boswellic acid (AKBA): 2,35–3,57 % CAS number: 67416-61-9 Analytical method ( 2 ) For the determination of 11-keto-β-boswellic acid and 3-O-acetyl-11-keto-β-boswellic acid (phytochemical markers) in the feed additive (olibanum extract): — high performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – European Pharmacopeia monograph ‘Indian Frankincense (Olibanum indicum)’ Horses Dogs - - - 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 estragole 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 %: — horses: 100 mg; — dogs: 330 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 and breathing protection. 29 August 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.