LegalizeCommission Implementing Regulation (EU) 2023/1707 of 7 September 2023 concerning the authorisation of 2-acetylfuran and 2-pentylfuran as feed additives for all animal species (Text with EEA relevance)
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| 8.9.2023 | EN | Official Journal of the European Union | L 221/27 |
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) 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) The substances 2-acetylfuran and 2-pentylfuran were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of feed additives as existing products, 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 2-acetylfuran and 2-pentylfuran 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’. The applications were 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 applicant withdrew the application for water for drinking for all the substances concerned.
- (5) That application concerns the authorisation of 2-acetylfuran and 2-pentylfuran as feed additives for all animal species, to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’.
- (6) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 February 2023 3 that, under the proposed conditions of use 2-acetylfuran and 2-pentylfuran are safe for all animals, consumers and the environment. It also concluded that 2-acetylfuran and 2-pentylfuran should be considered as irritant to skin and eyes and the respiratory tract, and as dermal and respiratory sensitisers. The Authority further concluded that the additives are efficacious to flavour feed. The Authority does not consider that there is a need for specific requirements of post-market monitoring. 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.
- (7) In view of the above, the Commission considers that 2-acetylfuran and 2-pentylfuran, satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. 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) Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.
- (9) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
- (10) 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’, is authorised as a feed additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 28 March 2024 in accordance with the rules applicable before 28 September 2023 may continue to be placed on the market and used until the existing stocks are exhausted.
Compound feed and feed materials containing the substances specified in the Annex, which are produced and labelled before 28 September 2024 in accordance with the rules applicable before 28 September 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
Compound feed and feed materials containing the substances specified in the Annex, which are produced and labelled before 28 September 2025 in accordance with the rules applicable before 28 September 2023 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.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 September 2023.
For the Commission
The President
Ursula VON DER LEYEN
Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
EFSA Journal 2023;21(3):7868.
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 of active substance/kg of complete feedingstuff with a moisture content of 12 % | mg of active substance/kg of complete feedingstuff 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 |
| 2b13054 | 2-Acetylfuran | Additive composition 2-Acetylfuran Liquid form Characterisation of active substance 2-Acetylfuran Produced by chemical synthesis Purity: min. 97 % Chemical formula: C6H6O2 CAS number: 1192-62-7 FLAVIS: 13.054 Analytical method 4 For the identification of 2-acetylfuran in the feed additives and flavouring premixtures: — Gas chromatography-mass spectrometry with retention time locking (GC-MS-RTL) | All animal species | — | — | — | 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. 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 %: 0,5 mg.’ 4. 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 3. 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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. | 28 September 2033 |
| 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 of active substance/kg of complete feedingstuff with a moisture content of 12 % | mg of active substance/kg of complete feedingstuff 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 |
| 2b13059 | 2-Pentylfuran | Additive composition 2-Pentylfuran Liquid form Characterisation of active substance 2-Pentylfuran Produced by chemical synthesis Purity: min. 99 % Chemical formula: C9H14O CAS number: 3777-69-3 FLAVIS: 13.059 Analytical method 5 For the identification of 2-pentylfuran in the feed additives and flavouring premixtures: — Gas chromatography-mass spectrometry with retention time locking (GC-MS-RTL) | All animal species | — | — | — | 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. 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 %: 0,5 mg.” 4. 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 3. 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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. | 28 September 2033 |
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.
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.
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