COMMISSION IMPLEMENTING REGULATION (EU) 2021/485

23.3.2021 | EN | Official Journal of the European Union | L 100/3 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2021/485 of 22 March 2021 concerning the authorisation as feed additives of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs (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) 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) | Ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These additives 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 ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs. ---|--- (4) | The applicant requested ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe 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 ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe in water for drinking should not be allowed. ---|--- (5) | 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. ---|--- (6) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 May 2020 (3) that, under the proposed conditions of use ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe do not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe should be considered as irritants to skin and eyes and the respiratory tract and as skin sensitisers. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. ---|--- (7) | The Authority concluded, that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe are recognised to flavour food and their function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. ---|--- (8) | The assessment of ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these substances should be authorised [as specified in the Annex to this Regulation]. ---|--- (9) | Restrictions and 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. ---|--- (10) | The fact that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe are not authorised for use as a flavourings in water for drinking, does not preclude their use in compound feed which is administered via water. ---|--- (11) | 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 allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. ---|--- (12) | 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 feed additives in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Use in water for drinking The authorised substances specified in the Annex shall not be used in water for drinking. Article 3 Transitional measures 1\. The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 12 October 2021 in accordance with the rules applicable before 12 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted. 2\. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 12 April 2022 in accordance with the rules applicable before 12 April 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3\. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 12 April 2023 in accordance with the rules applicable before 12 April 2021 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 4 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, 22 March 2021. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 268, 18.10.2003, p. 29. (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 2020;18(6):6147. * * * ANNEX Identification number of the additive | Name of the holder of authorisation | 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 2b489-eo | - | Ginger essential oil | Additive composition Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe. Characterisation of the active substance Essential oil derived by steam distillation from the dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe (1). | — | α-zingiberene: 29–40 % ---|--- — | β-sesquiphellandrene: 8–14 % ---|--- — | ar-curcumene: 5–12 % ---|--- — | α-farnesene: 4–10 % ---|--- — | camphene: 2–10 % ---|--- — | β-bisabolene: 2–9 % ---|--- CAS number: 8007-08-7, EINECS number: 283-634-2 FEMA number: 2522 CoE number 489 Liquid form Analytical method (2) For the quantification of alpha-zingiberene, beta-sesquiphellandrene and ar- curcumene in the feed additive: — | Gas chromatography coupled to mass spectrometry (GC-MS) (full scan mode) using Retention Time Locking (RTL) methodology (or standard substances of the phytochemical markers) with (or without) gas chromatography coupled to flame ionisation detection (GC-FID) based on the ISO 11024 standard method. ---|--- 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 and premixtures the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: | — | veal calves (milk replacer): 80 mg, ---|--- — | other species or categories of animals: 20 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. | The mixture of ginger essential oil with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs. ---|--- 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. ---|--- 12 April 2031 2b489-or | | Ginger oleoresin | Additive composition Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe. Characterisation of the active substance Ginger oleoresin obtained by steam distillation and solvent extraction of dried rhizomes of Zingiber officinale Roscoe as defined by the Council of Europe (1). Essential oil: 25-30 (w/w) Total gingerols: 0,5–8 % (w/w) | — | 6-Gingerol ---|--- — | 8-Gingerol ---|--- — | 10-Gingerol ---|--- Total shogaols: 3–6 % (w/w) — | 6 Shogaol ---|--- — | 8-Shogaol ---|--- Humidity and volatiles: 25-30 (w/w) CoE number: 489 Liquid form Analytical method (2) For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger oleoresin): — | High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685 ---|--- | — | Chickens for fattening ---|--- — | Laying hens ---|--- — | Turkeys for fattening. ---|--- — | Piglets ---|--- — | Pigs for fattening ---|--- — | Sows ---|--- — | Dairy cows ---|--- — | Veal calves (milk replacers) ---|--- — | Cattle for fattening ---|--- — | Sheep and goats ---|--- — | Horses ---|--- — | Rabbits ---|--- — | Fish ---|--- — | Pets ---|--- - | - | - | | 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 and premixtures the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 % and for milk replacers with a moisture content of 5,5 %: | — | chickens for fattening: 5 mg; ---|--- — | laying hens and rabbits: 7 mg; ---|--- — | turkeys for fattening: 6 mg; ---|--- — | piglets: 8mg; ---|--- — | pigs for fattening: 10 mg; ---|--- — | sows: 13 mg; ---|--- — | dairy cows: 12 mg; ---|--- — | veal calves (milk replacers): 21 mg; ---|--- — | cattle for fattening: 19 mg; ---|--- — | sheep, goats, horses and fish: 20 mg; ---|--- — | pets: 1 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. | The mixture of ginger oleoresin with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs. ---|--- 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. ---|--- 12 April 2031 2b489-t | | Ginger tincture | Additive composition Ginger tincture obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture. Characterisation of the active substance Ginger tincture is obtained by extraction of ground dried rhizomes of Zingiber officinale Roscoe using an ethanol/water mixture as defined by the Council of Europe (1) Solvent (ethanol/water, 90/10): 97-98 % (w/w) Dry matter: 2-3 % (w/w) Total gingerols: 0,14-0,11 % (w/w) | — | 6-Gingerol ---|--- — | 8-Gingerol ---|--- — | 10-Gingerol ---|--- Total shogaols: 0,043-0,031 % (w/w) — | 6 Shogaol ---|--- — | 8-Shogaol ---|--- Analytical method (2) For the quantification of the phytochemical markers: total gingerols and total shogaols in the feed additive (ginger tincture): — | High performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – ISO 13685 ---|--- | — | Horses ---|--- — | Dogs ---|--- - | - | - | | 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 and premixtures the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: | — | Horses 1,58 mL ---|--- — | Dogs 1,81 mL’ ---|--- 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. | The mixture of ginger tincture with other authorised additives obtained from Zingiber officinale Roscoe shall be not be allowed in feedingstuffs. ---|--- 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. ---|--- 12 April 2031 * * * (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://ec.europa.eu/jrc/en/eurl/feed- additives/evaluation-reports * * *