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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 nutritionnote, 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 and renewing such an authorisation.
(2)A preparation of benzoic acid, thymol, eugenol and piperine (‘the preparation’) was authorised for a period of 10 years as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying by Commission Implementing Regulation (EU) 2015/1426note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying. The application included a proposal for amending the conditions of the original authorisation, consisting of an increase of the maximum benzoic acid content from 83 % to 85 % and of the maximum thymol content from 1,9 % to 2 %. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application was also submitted for the authorisation of the preparation for use in turkeys for fattening and poultry reared for reproduction. The application requested that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of Regulation (EC) No 1831/2003.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 December 2025note that the applicant has provided evidence that the preparation remains safe for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying, as well as for the consumers and the environment. It concluded that the extension of use to all poultry species for fattening or reared for laying/reproduction would not affect these conclusions, thereby considering the preparation safe for all target species, the consumer and the environment, and that the proposed amendment of the conditions of the original authorisation is of no concern. It also concluded that the preparation should be considered irritant to skin, eyes and respiratory tract and a skin and respiratory sensitiser. The Authority further concluded that the preparation is efficacious in all poultry species for fattening or reared for laying/reproduction at 300 mg/kg complete feed. It did not consider that there is a need for specific requirements of post-market monitoring.
(5)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that the preparation satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying. In addition, that preparation should be authorised for turkeys for fattening and poultry reared for reproduction, thus extending the authorisation to all poultry for fattening and all poultry reared for laying or reproduction. It is appropriate to provide for ensuring the safety for the target species in case of simultaneous use of the preparation with other additives containing thymol, eugenol or piperine. 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
(7)As a consequence of the renewal of the authorisation of the preparation as a feed additive, Implementing Regulation (EU) 2015/1426 should be repealed.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(9)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 1Renewal of authorisation#
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, for use in chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying is renewed subject to the conditions laid down in that Annex.
Article 2Authorisation#
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition for turkeys for fattening and poultry reared for reproduction, subject to the conditions laid down in that Annex.
Article 3Repeal#
Implementing Regulation (EU) 2015/1426 is repealed.
Article 4Transitional measures#
1.The preparation of benzoic acid, thymol, eugenol and piperine, as authorised by Implementing Regulation (EU) 2015/1426 and premixtures containing that additive, which are intended for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying, and which are produced and labelled before 8 April 2027 in accordance with the rules applicable before 8 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying and which are produced and labelled before 8 October 2027 in accordance with the rules applicable before 8 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 5Entry 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.
| Identification number of the additive | Name of the holder of authorisation | Name of the 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 of the additive/kg of complete feed with a moisture content of 12 % | |||||||||
| Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | |||||||||
| 4d10 | DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. z o. o. | Preparation of benzoic acid, thymol, eugenol, piperine | Additive compositionPreparation of benzoic acid, thymol, eugenol, piperine having a content of:benzoic acid 80 %-85 %thymol 1 %-2 %eugenol 0,5 %-1 %piperine 0,05 %-0,1 %benzyl salicylate, iso-amyl salicylate and trans-anethole ≤ 0,6 %.Solid form.Characterisation of the active substancesBenzoic acid (≥ 99 % purity), C7H6O2, CAS number 65-85-0Thymol (≥ 98 % purity), C10H14O, CAS number 89-83-8Eugenol (≥ 98 % purity), C10H12O2, CAS number 97-53-0Piperine (≥ 95 % purity), C17H19O3N, CAS number 94-62-2Isoamyl salicylate (≥ 98 % purity), CAS number 87-20-7Benzyl salicylate (≥ 98 % purity), CAS number 118-58-1Trans-anethole (≥ 99 % purity), CAS number 4180-23-8.Analytical methodsnoteFor the determination benzoic acid in the feed additive and premixtures: Reverse Phase High-Performance Liquid Chromatography coupled to an Ultraviolet detector (RP-HPLC-UV)For the determination benzoic acid in compound feed: Gas Chromatography Isotope Dilution Mass Spectrometry (GC-IDMS)For the determination of thymol, eugenol and piperine in the feed additive: Gas Chromatography coupled to a Flame Ionisation Detector (GC-FID) | Poultry for fatteningPoultry reared for laying or reproduction | — | 300 | 300 | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2. The additive shall not be used with other sources of benzoic acid or benzoates.3. The simultaneous use of this preparation with other feed additives is permitted, provided that the contents of thymol, eugenol and piperine in feed materials and compound feed are lower than those that would result from the use of the other authorised feed additive(s) with the highest contents of thymol, eugenol and piperine, at their maximum or recommended maximum content for the relevant animal species or category.4. 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 respiratory, eye and skin protective equipment. | 8 October 2036 |
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