Date: 2022-08-23Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2022/1419 authorises buchu leaf essential oil from Agathosma betulina P.J. Bergius Pillans as a sensory feed additive (flavouring compound) for all animal species, excluding use in drinking water. The regulation specifies conditions for its use, labeling, and control. Transitional measures allow continued use of existing stocks produced and labeled under previous rules until September 12, 2023/2024, with a final deadline of March 12, 2023, for production and labeling of the substance and premixtures.
Key Points / Main Content:
* **Authorisation:** Buchu leaf essential oil from Agathosma betulina P.J. Bergius Pillans is authorised as a feed additive for all animal species, classified as a sensory additive (flavouring compound).
* **Restriction:** Use in drinking water is not permitted.
* **Safety:** The additive is considered an irritant to skin and eyes and a dermal and respiratory sensitiser; protective measures are required for users.
* **Labelling:**
* A recommended maximum content of the active substance per kg of complete feed must be indicated on the label.
* If the use level on the label of the premixture would result in exceeding the recommended maximum content, the functional group, identification number, name, and added amount of the active substance must be indicated.
* **Conditions of Use:**
* The additive must be incorporated into feed in the form of a premixture.
* Directions for use of the additive and premixtures must include storage conditions and stability to heat treatment.
* Mixing with other additives containing methyleugenol is prohibited.
* **Transitional Measures:**
* Substance and premixtures produced and labelled before March 12, 2023, under previous rules may be placed on the market and used until existing stocks are exhausted.
* Compound feed and feed materials produced and labelled before September 12, 2023 (for food-producing animals) or September 12, 2024 (for non-food-producing animals) under previous rules may be placed on the market and used until existing stocks are exhausted.
* **Control:** Certain conditions are provided for better control, including indication of recommended content on the label and specific information on premixtures when content is exceeded.
* **Analytical Method:** Gas chromatography coupled with flame ionisation detection GCFID based on ISO 11024 is the method for determining d-limonene and d,l-isomenthone phytochemical markers.
* **Expiration Date:** The authorisation expires on 12 September 2032.
Impact Analysis:
* **Feed Additive Producers/Manufacturers:**
* *Impact:* Must comply with the new authorisation conditions, including labelling requirements, safety measures, and restrictions on use in drinking water. They need to update production and labeling processes.
* *Action Required:* Adjust formulations, update labels, implement safety protocols, and ensure compliance with the regulation by the specified deadlines.
* **Feed Business Operators (including Premixture Producers):**
* *Impact:* Responsible for establishing operational procedures and organizational measures to minimize risks by inhalation, dermal contact, or eye contact during the use of the additive and premixtures.
* *Action Required:* Develop and implement safety protocols, provide personal protective equipment where risks cannot be eliminated, and ensure user compliance with safety measures.
* **Animal Feed Users (Farmers, Animal Owners):**
* *Impact:* Need to be aware of the new conditions of use for buchu leaf essential oil, including the recommended maximum content in feed and any required safety measures.
* *Action Required:* Follow updated instructions for feed preparation and handling, and implement safety precautions as advised by feed business operators.
* **European Food Safety Authority (EFSA) and Reference Laboratory:**
* *Impact:* EFSA's opinion formed the basis for the authorisation. The Reference Laboratory provides the analytical method for enforcement.
* *Action Required:* Continue to provide scientific support and analytical methods for monitoring and enforcement of the regulation.
* **Member States:**
* *Impact:* Responsible for enforcing the regulation within their jurisdiction.
* *Action Required:* Implement the regulation, monitor compliance, and take appropriate action against non-compliant operators.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Council Directive 70/524/EEC: Council Directive concerning additives in feedingstuffs.
Agathosma betulina P.J. Bergius Pillans: Botanical name of the plant species from which buchu leaf essential oil is derived.
Buchu leaf essential oil: A feed additive derived from the leaves of Agathosma betulina P.J. Bergius Pillans.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures proposed by the European Commission relating to food safety.
L 218/12 EN Official Journal of the European Union 23.8.2022
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).
(2) Buchu leaves oil was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for
all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in
accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the re-evaluation of an essential oil from the leaves of Agathosma betulina (P.J. Bergius)
Pillans (buchu leaf essential oil) for all animal species.
(4) The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional
group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under
Article 7(3) of Regulation (EC) No 1831/2003.
(5) The applicant requested the additive to be authorised also for use in water for drinking. However, Regulation (EC)
No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore,
the use of buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans in water for drinking should not be
allowed.
(6) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022(3)that, under the
proposed conditions of use, buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans does not have
adverse effects on animal health, consumer health or the environment. The Authority also concluded that buchu
leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans should be considered as an irritant to skin and eyes,
and as a dermal and respiratory sensitiser. Therefore, the Commission considers that appropriate protective
measures should be taken to prevent adverse effects on human health, in particular as regards the users of the
additive.
(7) The Authority further concluded, that buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans is
recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no
further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of
the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) EFSA Journal 2022;20(3):7160.23.8.2022 EN Official Journal of the European Union L 218/13
(8) The assessment of buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans shows that the conditions for
authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of
that substance should be authorised as specified in the Annex to this Regulation.
(9) Certain conditions should be provided for to allow better control. In particular, a recommended content should be
indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on
the label of premixtures.
(10) The fact that buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans is not authorised for use as a
flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.
(11) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the substance concerned, it is appropriate to allow a transitional period for interested parties to prepare
themselves to meet the new requirements resulting from the authorisation.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
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 this substance, which are produced and labelled
before 12 March 2023in accordance with the rules applicable before 12 September 2022may 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 2023in accordance with the rules applicable before 12 September 2022may 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 2024in accordance with the rules applicable before 12 September 2022may 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.L 218/14 EN Official Journal of the European Union 23.8.2022
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 August 2022.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
content content
Identification Species or
Composition, chemical formula, description, Maximum End of period of
number of the Additive category of mg additive/kg of Other provisions
analytical method. age authorisation
additive animal complete feed with a
moisture content of
12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b85c-eo Buchu leaf essential Additive composition All - - - 1. The additive shall be incorporated into 12.9.2032
oil animal the feed in the form of a premixture.
Buchu leaf essential oil obtained from the species
leaves of Agathosma betulina (P.J. Bergius) except 2. In the directions for use of the additive
Pillans cats and premixtures, the storage conditions
and stability to heat treatment shall be
Liquid form Cats - - 0,2 indicated.
Methyleugenol ≤ 0,17 %
3. Mixture with other additives containing
methyleugenol is not permitted.
Characterisation of the active substance
Buchu leaf essential oil produced by steam 4. On the label of the additive the following
distillation from the leaves of Agathosma shall be indicated:
betulina (P.J. Bergius) Pillans as defined by the ‘Recommended maximum content of the
Council of Europe(1). active substance per kg of complete
feedingstuff with a moisture content of 12 %:
d,l-Isomenthone: 19–27 % — chickens for fattening and other minor
d-Limonene: 19–26 % poultry species for fattening: 0,1 mg;
2-Hydroxypiperitone (or diosphenol): 8–17 % — laying hens and other minor poultry spe
p-Menthan-3-one: 5–12 % cies for laying and breeding purposes,
Pulegone: 1,5–8 % turkeys for fattening and rabbits:
0,15 mg;
CAS number: 68650-46-4 — piglets of all Suidae species: 0,20 mg;
CoE number: 85c — all Suidae for fattening: 0,25 mg;
FEMA number: 2169 — sows and dairy ruminants: 0,30 mg;
23.8.2022
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Journal
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Union
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218/15Analytical method(2) — ruminants for fattening and horses:
0,45 mg;
For the determination of d-limonene and d,l- — calves (milk replacer), dogs, fish and
isomenthone (phytochemical markers) in the ornamental fish: 0,5 mg;
feed additive (buchu leave essential oil): — other species, except cats: 0,1 mg.’
— gas chromatography coupled with flame
5. The functional group, the identification
ionisation detection (GC-FID) (based on
number, the name and the added amount
ISO 11024)
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 re
ferred to in point 4.
6. For users of the additive and premixtures,
feed business operators shall establish
operational procedures and organisa
tional 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 addi
tive and premixtures shall be used with
personal protective equipment, including
skin, eye and breathing protection.
(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
L
218/16
EN
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