Commission Implementing Regulation (EU) 2024/1186 of 24 April 2024 concerning the authorisation of cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl as feed additives for certain animal species
Date: 2024-04-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, aromatic plant, essential oil, fattening, fish, flavouring, livestock, market approval, poultry, withdrawal from the market




L_202401186EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1186


25.4.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/1186
of 24 April 2024
         
concerning the authorisation of cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl as feed additives for certain 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 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) and Article 10(5) 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 authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).












(2)


The substances cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These substances were subsequently entered in the Register of Feed Additives as existing products, in accordance with Article 10(1), point (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 authorisation of cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl as feed additives for all animal species. The applicant requested the additives 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.












(4)


The applicant requested the additives to be authorised for use also 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 those additives in water for drinking should not be allowed.












(5)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022 (3) that, under the proposed conditions of use, cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl are safe for short-living animals (animals intended for fattening), including piglets and other minor Suidae. It also concluded that both additives are safe for the consumers and the environment. The Authority indicated that, owing to the presence of styrene in cinnamon bark essential oil and cinnamon leaf essential oil, it is not in the position to conclude on the safety of the additives for long-living animals and reproductive animals including those animals reared for laying/breeding/reproduction. In addition, the Authority concluded that cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl should be considered as irritant to skin and eyes, and as dermal and respiratory sensitisers. It also stated that, based on the presence of safrole ≥ 0,1 %, cinnamon leaf oil and bark oil are classified as carcinogen (category 1B) and should be handled accordingly. The Authority further concluded that since the substances are recognised to flavour food and since their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.












(6)


Subsequently, the applicant withdrew the application for authorisation of cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl for all animal species and categories except piglets, except piglets of minor Suidae, except animal species for fattening (other than Equidae), except salmonids (other than brood stock) and except minor fin fish (other than brood stock).












(7)


In view of the above, the Commission considers that cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 as regards animal species for fattening (except Equidae), as regards salmonids (except brood stock), as regards minor fin fish (except brood stock), as regards piglets and as regards piglets of minor Suidae. Accordingly, the use of those additives should be authorised. For cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl, the Commission considers that the presence of the substances of concern safrole, methyleugenol and styrene requires to set a maximum content in complete feed and to prohibit the combination of these additives with other additives containing the same substances of concern. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives.












(8)


Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the Commission to adopt a Regulation requiring the withdrawal from the market of feed additives for which no applications as required by Article 10(2) of Regulation (EC) No 1831/2003 were submitted before the deadline provided for in that provision. Similarly, a Regulation should be adopted concerning feed additives for which an application was submitted but subsequently withdrawn.












(9)


In the case of feed additives for which an application has been withdrawn for certain animal species or categories, the withdrawal from the market should only concern those animal species or categories.












(10)


Therefore, cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl should be withdrawn from the market as regards the animal species and categories which are not the subject of the authorisation granted by this Regulation.












(11)


In so far as this Regulation authorises cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl as a feed additives, safety reasons do not require the immediate application of the modifications to the conditions of authorisation of that substance in respect of the animal species and categories which are covered by the authorisation granted by this Regulation. It is therefore appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.












(12)


In addition, in so far as the feed additives are withdrawn from the market, it is also appropriate to allow for a transitional period within which existing stocks of the additives, premixtures, feed materials and compound feed which have been produced with those additives, may be used up also in respect of the animal species and categories of animals which are not covered by the authorisation granted by this Regulation, in order to allow interested parties to adapt to the obligation to withdraw those products from the market.












(13)


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 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

Withdrawal from the market

The feed additives cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl as authorised pursuant to Directive 70/524/EEC, shall be withdrawn from the market in respect of the animal species and categories other than those mentioned in the Annex.


Article 3

Transitional measures related to the authorisation


1.   The feed additives referred to in Article 2 and premixtures containing those additives, which are produced and labelled before 15 November 2024 in accordance with the rules applicable before 15 May 2024, may continue to be placed on the market and used in respect of the animal species and categories mentioned in the Annex until the stocks concerned are exhausted.


2.   Compound feed and feed materials containing the feed additives referred to in Article 2, which are produced and labelled before 15 May 2025 in accordance with the rules applicable before 15 May 2024, may continue to be placed on the market and used in respect of the animal species and categories mentioned in the Annex until the stocks concerned are exhausted.



Article 4

Transitional measures related to the withdrawal from the market


1.   Existing stocks of the feed additives referred to in Article 2 may continue to be placed on the market and used in respect of the animal species and categories other than those mentioned in the Annex until 15 May 2025.


2.   Premixtures produced with the feed additives referred to in paragraph 1 may continue to be placed on the market and used in respect of the animal species and categories other than those mentioned in the Annex until 15 August 2025.


3.   Compound feed and feed materials produced with the feed additives referred to in paragraph 1 or with the premixtures referred to in paragraph 2 may continue to be placed on the market and used in respect of the animal species and categories other than those mentioned in the Annex used until 15 May 2026.



Article 5

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.





This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 April 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, http://data.europa.eu/eli/dir/1970/524/oj).

(3)  
            EFSA Journal 2022;20(10):7601.




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





2b133-eo


Cinnamon bark essential oil



Additive composition

Essential oil obtained from the bark of Cinnamomum verum J. Presl
Liquid form

Characterisation of the active substance

Essential oil obtained from the bark of Cinnamomum verum J. Presl by steam distillation and then separated from the aqueous phase by decantation as defined by the Council of Europe (1).
Specifications:






—


(E)-Cinnamaldehyde: 55–75 %










—


Eugenol: ≤ 7,5 %










—


β-Caryophyllene: 1.0–7,5 %










—


Linalool: 1,0–7,5 %










—


Safrole:≤ 0,34 %










—


Methyleugenol: ≤ 0,04 %










—


Styrene ≤ 0,024 %










—


Camphor: ≤ 0,018 %










—


Coumarin: ≤ 0,01 %




CAS number: 8015-91-6
Einecs number: 283–479-0
FEMA number: 2291
CoE number: 133

Analytical method
 (2)

For the determination of
(E)-cinnamaldehyde (phytochemical marker) in the feed additive: gas chromatography coupled with flame ionisation detection (GC-FID)


Pigs for fattening


—


—


25








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.


This additive shall not be used in combination with other additives containing safrole, methyleugenol and styrene.










4.


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.






15 May 2034




Pigs for fattening of minor Suidae


—


—


50




Piglets and piglets of minor Suidae


 


 


50




Cattle for fattening, sheep for fattening, minor ruminants for fattening and calves for fattening


—


—


10




Chickens for fattening, turkeys for fattening and minor poultry for fattening


—


—


5




Salmonids and minor finfish except brood stock


—


—


5




Other minor species for fattening except Equidae


—


—


5




















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 active substance/kg of complete feed with a moisture content of 12 %





Category: Sensory additives. Functional group: Flavouring compounds





2b133i-eo


Cinnamon leaf essential oil



Additive composition

Essential oil obtained from the leaves of Cinnamomum verum J. Presl
Liquid form

Characterisation of the active substance

Essential oil obtained from the leaves of Cinnamomum verum J. Presl by steam distillation and then separated from the aqueous phase by decantation as defined by the Council of Europe (3).
Specifications:






—


(E)-Cinnamaldehyde: ≤ 3 %










—


Eugenol: 70-85 %










—


Eugenyl acetate: 1,3–5,0 %










—


Benzyl benzoate: 2-4,5 %










—


Safrole:≤ 1,09 %










—


Methyleugenol: ≤ 0,030 %










—


Camphor: ≤ 0,007 %










—


Coumarin: ≤ 0,01 %










—


Styrene: ≤ 0,013 %




CAS number: 8015-91-6
Einecs number: 283–479-0
FEMA number: 2292
CoE number: 133

Analytical method
 (4)

For the determination of (E)-
cinnamaldehyde (phytochemical marker) in the feed additive: gas chromatography coupled with flame ionisation detection (GC-FID)


Pigs for fattening


—


—


50








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.


This additive shall not be used in combination with other additives containing safrole, methyleugenol and styrene.










4.


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.






15 May 2034




Pigs for fattening of minor Suidae


—


—


50




Piglets and piglets of minor Suidae


 


 


50




Cattle and sheep for fattening, minor ruminants for fattening and calves for fattening


—


—


50




Chickens for fattening and minor poultry species for fattening


—


—


40




Turkeys for fattening


—


—


50




Rabbits for fattening


—


—


50




Salmonids and minor finfish except brood stock


—


—


25




Other minor species for fattening except Equidae


—


—


25






(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.



ELI: http://data.europa.eu/eli/reg_impl/2024/1186/oj
ISSN 1977-0677 (electronic edition)