My bookmarksSign up free
Source

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)

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)

Implementing Regulation (EU) 2022/1419 · Regulation · 4 articles

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

Article 1

Open ↗

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.

Transitional measures

Article 2

Open ↗

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.

Entry into force

Article 3

Open ↗

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

Open ↗

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 2b85c-eo 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): — 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 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 %: — chickens for fattening and other minor poultry species for fattening: 0,1 mg; — laying hens and other minor poultry species for laying and breeding purposes, turkeys for fattening and rabbits: 0,15 mg; — piglets of all Suidae species: 0,20 mg; — all Suidae for fattening: 0,25 mg; — sows and dairy ruminants: 0,30 mg; — ruminants for fattening and horses: 0,45 mg; — calves (milk replacer), dogs, fish and ornamental fish: 0,5 mg; — 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 - - 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

Other acts of the same type
Commission Implementing Regulation (EU) 2018/1990 of 11 December 2018 establishing the forms referred to in Council Regulation (EU) 2016/1104 implementing enhanced cooperation in the area of jurisdiction, applicable law and the recognition and enforcement of decisions in matters of the property consequences of registered partnershipsRegulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (Text with EEA relevance.)Regulation (EU) 2019/2 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 1008/2008 on common rules for the operation of air services in the CommunityRegulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance)Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)Commission Delegated Regulation (EU) 2019/330 of 11 December 2018 amending Annexes I and V to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (Text with EEA relevance.)Council Implementing Regulation (EU) 2018/1929 of 10 December 2018 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of UkraineCouncil Implementing Regulation (EU) 2018/1931 of 10 December 2018 implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measuresn directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the CongoCouncil Regulation (EU) 2018/1933 of 10 December 2018 amending Regulation (EU) No 356/2010 imposing certain specific restrictive measures directed against certain natural or legal persons, entities or bodies, in view of the situation in SomaliaCouncil Implementing Regulation (EU) 2018/1934 of 10 December 2018 implementing Article 20(3) of Regulation (EU) 2015/735 concerning restrictive measures in respect of the situation in South SudanCommission Implementing Regulation (EU) 2018/1937 of 10 December 2018 replacing Annex X to Council Regulation (EC) No 4/2009 on jurisdiction, applicable law, recognition and enforcement of decisions and cooperation in matters relating to maintenance obligations

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

Contents

What to look at next