LegalizeCommission Implementing Regulation (EU) 2024/239 of 15 January 2024 correcting and amending Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320
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) The use of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck as feed additives was authorised for all animal species by Commission Implementing Regulation (EU) 2022/1421 (2) for a 10-year period. In Article 2 of Implementing Regulation (EU) 2022/1421, transitional measures concerning feed materials and compound feed containing the additives concerned and which are intended for non-food producing animals were erroneously omitted. Furthermore, in its opinion of 29 September 2021 (3), the European Food Safety Authority (‘the Authority’) could not conclude on the safety of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck as feed additives for dogs, cats, ornamental fish and ornamental birds, because they are not normally exposed to citrus by-products. The Authority also clarified that folded orange oil identified as 2b143-f-ii in the Annex to Implementing Regulation (EU) 2022/1421 is not intended for use in horses, rabbits, dogs, cats, ornamental fish and ornamental birds. Those species should therefore not have been included in the column ‘species or category of animal’ of the Annex to Implementing Regulation (EU) 2022/1421 in relation to the additives concerned. The title of Implementing Regulation (EU) 2022/1421 should be adjusted accordingly to reflect the fact that the authorisation of the additives concerned relates to certain animal species only.
(2) The use of bitter orange extract as a feed additive was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/652 (4) for a 10-year period. In its opinion of 23 June 2021 (5), the Authority could not conclude on the safety of bitter orange extract as a feed additive for dogs, cats and ornamental fish, because they are not normally exposed to citrus by-products. In addition, an entry covering other animal species than those mentioned in the Annex to Implementing Regulation (EU) 2022/652 was erroneously omitted. Therefore, the column ‘species or category of animal’ of the Annex to Implementing Regulation (EU) 2022/652 should refer to all animal species except dogs, cats, ornamental fish as well as ornamental birds, which are also not normally exposed to citrus by-products according to the conclusions of the Authority in its opinion of 29 September 2021.
(3) The use of expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil as feed additives was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/1490 (6) for a 10-year period. In its opinion of 18 March 2021 (7), the Authority could not conclude on the safety of expressed lemon oil and its residual fraction and of lime oil as feed additives for companion animals and ornamental fish, because they are not normally exposed to citrus by-products. Ornamental fish should therefore not have been included in the column ‘species or category of animal’ of the Annex to Implementing Regulation (EU) 2022/1490 for the additive identified as 2b141-eo. In addition, an entry covering other animal species except dogs, cats, ornamental fish, as well as ornamental birds, which are also not normally exposed to citrus by-products according to the conclusions of the Authority in its opinion of 29 September 2021, was erroneously omitted and should therefore be included in the column ‘species or category of animal’ of the Annex to Implementing Regulation (EU) 2022/1490 for the additives identified as 2b139-eo, 2b139-rf and 2b141-eo. Finally, an entry covering ‘other animal species’ was erroneously omitted and should therefore be included in the column ‘species or category of animal’ of the Annex to Implementing Regulation (EU) 2022/1490 for the additive identified as 2b139-di.
(4) The use of expressed mandarin essential oil as a feed additive was authorised for poultry, pigs, ruminants, horses, rabbits and salmonids by Commission Implementing Regulation (EU) 2022/320 (8) for a 10-year period. In Article 2 of Implementing Regulation (EU) 2022/320, transitional measures concerning feed materials and compound feed containing the additive concerned and which are intended for non-food producing animals were erroneously omitted. Furthermore, an entry covering ‘other animal species’ was erroneously omitted in the column ‘species or category of animal’ of the Annex to Implementing Regulation (EU) 2022/320. In its opinion of 5 May 2021 (9), the Authority could not conclude on the safety of expressed mandarin essential oil as a feed additive for dogs, cats and ornamental fish, because they are not normally exposed to citrus by-products. In its opinion of 29 September 2021, the Authority concluded that ornamental birds are also not normally exposed to citrus by-products. Therefore, an entry covering other animal species except dogs, cats, ornamental fish and ornamental birds should be included in the column ‘species or category of animal’ of the Annex to Implementing Regulation (EU) 2022/320. The title of Implementing Regulation (EU) 2022/320 should be adjusted accordingly to reflect the fact that the authorisation of expressed mandarin essential oil relates to a broader list of animal species.
(5) Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320 should therefore be corrected accordingly.
(6) Since safety reasons do not require the immediate application of the corrections, it is appropriate to provide for an extension of the transitional periods laid down in Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320 for the interested parties to prepare themselves to meet the requirements resulting from those corrections. Those Implementing Regulations should therefore be amended accordingly.
(7) 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
Correction and amendment to Implementing Regulation (EU) 2022/1421
The title of Implementing Regulation (EU) 2022/1421 is replaced by the following:
‘Commission Implementing Regulation (EU) 2022/1421 of 22 August 2022 concerning the authorisation of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck as feed additives for certain animal species’.
Article 2 of Implementing Regulation (EU) 2022/1421 is replaced by the following:
‘Article 2
Transitional measures
The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 5 August 2024 in accordance with the rules applicable before 5 February 2024, 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 5 February 2025 in accordance with the rules applicable before 5 February 2024, 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 5 February 2026 in accordance with the rules applicable before 5 February 2024, 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.’
The Annex to Implementing Regulation (EU) 2022/1421 is replaced by Annex I to this Regulation.
Article 2
Correction and amendment to Implementing Regulation (EU) 2022/652
Article 2 of Implementing Regulation (EU) 2022/652 is replaced by the following:
‘Article 2
Transitional measures
The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 5 August 2024 in accordance with the rules applicable before 5 February 2024, may continue to be placed on the market and used until the existing stocks are exhausted.
Compound feed and feed materials containing the substance specified in the Annex, which are produced and labelled before 5 February 2025 in accordance with the rules applicable before 5 February 2024, 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 substance specified in the Annex, which are produced and labelled before 5 February 2026 in accordance with the rules applicable before 5 February 2024, 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.’
The Annex to Implementing Regulation (EU) 2022/652 is replaced by Annex II to this Regulation.
Article 3
Correction and amendment to Implementing Regulation (EU) 2022/1490
Article 2 of Implementing Regulation (EU) 2022/1490 is replaced by the following:
‘Article 2
Transitional measures
The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 5 August 2024 in accordance with the rules applicable before 5 February 2024, 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 5 February 2025 in accordance with the rules applicable before 5 February 2024, 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 5 February 2026 in accordance with the rules applicable before 5 February 2024, 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.’
The Annex to Implementing Regulation (EU) 2022/1490 is replaced by Annex III to this Regulation.
Article 4
Correction and amendment to Implementing Regulation (EU) 2022/320
The title of Implementing Regulation (EU) 2022/320 is replaced by the following:
‘Commission Implementing Regulation (EU) 2022/320 of 25 February 2022 concerning the authorisation of expressed mandarin essential oil as a feed additive for certain animal species’.
Article 2 of Implementing Regulation (EU) 2022/320 is replaced by the following:
‘Article 2
Transitional measures
The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 5 August 2024 in accordance with the rules applicable before 5 February 2024, may continue to be placed on the market and used until the existing stocks are exhausted.
Compound feed and feed materials containing the substance specified in the Annex, which are produced and labelled before 5 February 2025 in accordance with the rules applicable before 5 February 2024, 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 substance specified in the Annex, which are produced and labelled before 5 February 2026 in accordance with the rules applicable before 5 February 2024, 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.’
The Annex to Implementing Regulation (EU) 2022/320 is replaced by Annex IV to this Regulation.
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, 15 January 2024.
For the Commission The President Ursula VON DER LEYEN
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) 2022/1421 of 22 August 2022 concerning the authorisation of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck as feed additives for all animal species (OJ L 218, 23.8.2022, p. 27).
(3) Safety and efficacy of feed additives consisting of expressed sweet orange peel oil and its fractions from Citrus sinensis (L.) Osbeck for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(11):6891. doi: org/10.2903/j.efsa.2021.6891).
(4) Commission Implementing Regulation (EU) 2022/652 of 20 April 2022 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (OJ L 119, 21.4.2022, p. 74).
(5) Safety and efficacy of a feed additive consisting of a flavonoid-rich dried extract of Citrus x aurantium L. fruit (bitter orange extract) for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(7):6709. doi: 10.2903/j.efsa.2021.6709).
(6) Commission Implementing Regulation (EU) 2022/1490 of 1 March 2022 concerning the authorisation of expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil as feed additives for certain animal species (OJ L 234, 9.9.2022, p. 1).
(7) Safety and efficacy of feed additives consisting of expressed lemon oil and its fractions from Citrus limon (L.) Osbeck and of lime oil from Citrus aurantiifolia (Christm.) Swingle for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(4):6548. doi: org/10.2903/j.efsa.2021.6548).
(8) Commission Implementing Regulation (EU) 2022/320 of 25 February 2022 concerning the authorisation of expressed mandarin essential oil as a feed additive for poultry, pigs, ruminants, horses, rabbits and salmonids (OJ L 55, 28.2.2022, p. 41).
(9) Safety and efficacy of a feed additive consisting of expressed mandarin oil from the fruit peels of Citrus reticulata Blanco for use in all animal species (FEFANA asbl) (EFSA Journal 2021;19(6):6625. doi: 10.2903/j.efsa.2021.6625).
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