LegalizeCommission Implementing Regulation (EU) 2024/1195 of 24 April 2024 concerning the authorisation of cassia essential oil from Cinnamomum aromaticum Nees as a feed additive for certain animal species
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2024/1195 | 25.4.2024 |
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 substance cassia essential oil from Cinnamomum aromaticum Nees was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This substance was subsequently entered in the Register of Feed Additives as an existing product, 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 cassia essential oil from Cinnamomum aromaticum Nees as a feed additive for all animal species, requesting 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.
- (4) The applicant requested the additive 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 that additive 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, cassia essential oil from Cinnamomum aromaticum Nees is safe for short-living animals (animals intended for fattening), including piglets and minor Suidae. It also concluded that it is safe for the consumers and the environment. The Authority indicated that, owing to the presence of styrene in cassia leaf oil, it is not in the position to conclude on the safety of the additive for long-living animals and reproductive animals including those animals reared for laying/breeding/reproduction. In addition, the Authority concluded that when handling the essential oil, exposure of unprotected users to styrene cannot be excluded and that therefore, to reduce the risk, the exposure of the users should be minimised. The Authority further concluded that since the substance is recognised to flavour food and since its 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 additive 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 cassia essential oil from Cinnamomum aromaticum Nees 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 cassia essential oil from Cinnamomum aromaticum Nees satisfies 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 fin fish (except brood stock), as regards piglets and as regards piglets of minor Suidae. Accordingly, the use of that additive should be authorised. The Commission considers that the presence of the substances of concern styrene and coumarins in cassia essential oil from Cinnamomum aromaticum Nees requires to set a maximum content in complete feed and to prohibit the combination of that additive 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 additive.
- (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, cassia essential oil from Cinnamomum aromaticum Nees 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 cassia essential oil from Cinnamomum aromaticum Nees as a feed additive, 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 additive is withdrawn from the market, it is also appropriate to allow for a transitional period within which existing stocks of the additive, premixtures, feed materials and compound feed which have been produced with that additive, 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 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.
Article 2
Withdrawal from the market
The feed additive cassia essential oil from Cinnamomum aromaticum Nees, 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 additive referred to in Article 2 and premixtures containing that additive, 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 additive 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 additive 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 additive 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 additive 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
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(10):7600.
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 |
|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | mg active substance/kg of complete feed with a moisture content of 12 % | mg active substance/kg of complete feed with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds | Category: Sensory additives. Functional group: Flavouring compounds |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Pigs for fattening | - | - | 61 | 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Pigs for fattening of minor Suidae | - | - | 51 | 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Piglets and piglets of minor Suidae | - | - | 51 | 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Calves for fattening | - | - | 100 | 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Cattle for fattening, sheep for fattening and minor ruminants for fattening | 60 | 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 styrene and coumarins. 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. | 10 May 2034 | ||
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Chickens for fattening and minor poultry for fattening | - | - | 28,5 | 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Turkeys for fattening | - | - | 38 | 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Rabbits 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Salmonids and minor finfish except brood stock | - | - | 125 | 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 styrene and coumarins. 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. | 10 May 2034 |
| 2b131-eo | Cassia essential oil | Additive composition Essential oil obtained from the leaves, stalks and twigs of Cinnamomum aromaticum Nees4 Liquid form Characterisation of the active substance Essential oil obtained from Cinnamomum aromaticum Nees by steam distillation of the leaves, stalks and twigs from as defined by the Council of Europe5. Specifications: (E)-Cinnamaldehyde: 70-89 % (E)-2-Methoxycinnamaldehyde: 0-15 % Cinnamyl acetate: ≤ 4 % Coumarin: ≤ 4 % Styrene: ≤ 0,1 % CAS number 8007-80-5 Einecs number: 284-635-0 FEMA number: 2258 CoE number: 131 Analytical method 6 For the determination of (E)-cinnamaldehyde (phytochemical marker) in the feed additive (cassia oil): — gas chromatography coupled with flame ionisation detection (GC-FID) or with mass spectrometry detection (GC-MS) | Other minor species for fattening except Equidae | - | - | 28,5 | 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 styrene and coumarins. 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. | 10 May 2034 |
4
Accepted synonyms Cinnamomum cassia (L.) J. Presl and Cinnamomum cassia Blume.
5
Natural sources of flavourings – Report No 2 (2007).
6
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/2024/1195/oj
ISSN 1977-0677 (electronic edition)
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