Commission Implementing Regulation (EU) 2018/242 of 15 February 2018 concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate as feed additives for all animal species (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2018/242of 15 February 2018concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate as feed additives for all animal species(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 nutritionOJ L 268, 18.10.2003, p. 29., 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 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECCouncil Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1)..(2)The substances, hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)-enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6-dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate ("substances concerned") were authorised without a time limit by 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) 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 the substances concerned as feed additives for all animal species. The applicant requested that those additives be classified in the additive category "sensory additives". That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 12 July 2016EFSA Journal 2016;14(8):4559. that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority has concluded that, since the substances concerned are efficacious when used in food as flavourings and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion can be extrapolated to feed. The applicant withdrew the application for water for drinking. However, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water.(5)Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, and on the labelling of feed materials and compound feed.(6)The Authority concluded that hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. 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)The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for 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.(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 1AuthorisationThe 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 2Transitional measures1.The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.2.Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 2018 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.Feed materials and compound containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 2018 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 3Entry into forceThis 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 February 2018.For the CommissionThe PresidentJean-Claude JunckerANNEX
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.Category: Sensory additives. Functional group: Flavouring compounds
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
2b02056—Hex-3(cis)-en-1-olAdditive compositionHex-3(cis)-en-1-olCharacterisation of the active substanceHex-3(cis)-en-1-olProduced by chemical synthesisPurity: min. 98 % assay as sum of (Z)- and (E)-isomers; min. 92 % of (Z)-isomerChemical formula: C6H12OCAS number: 928-96-1FLAVIS No: 02.056Method of analysisFor the determination of hex-3(cis)-en-1-ol in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTLAll 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b02093—Non-6-en-1-olAdditive compositionNon-6-en-1-olCharacterisation of the active substanceNon-6-en-1-olProduced by chemical synthesisPurity: min. 98 % assayChemical formula: C9H18OCAS number: 35854-86-5FLAVIS No: 02.093Method of analysisFor the determination of non-6-en-1-ol in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTLAll 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.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.15.3.2028
2b02094—Oct-3-en-1-olAdditive compositionOct-3-en-1-olCharacterisation of the active substanceOct-3-en-1-olProduced by chemical synthesisPurity: min. 96 % assay, as (Z)- isomer.Chemical formula: C8H16OCAS number: 20125-84-2FLAVIS No: 02.094Method of analysisFor the determination oct-3-en-1-ol in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTLAll 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.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.15.3.2028
2b05059—Non-6(cis)-enalAdditive compositionNon-6(cis)-enalCharacterisation of the active substanceNon-6(cis)-enalProduced by chemical synthesisPurity: min. 96 % assay; secondary component 6–9 % trans-6-nonenalChemical formula: C9H16OCAS number: 2277-19-2FLAVIS No: 05.059Method of analysisFor the determination non-6(cis)-enal in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTLAll 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg6.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.15.3.2028
2b05075—Hex-3(cis)-enalAdditive compositionHex-3(cis)-enalCharacterisation of the active substanceHex-3(cis)-enalProduced by chemical synthesisPurity: min. 97 % assayChemical formula: C6H10OCAS number: 6789-80-6FLAVIS No: 05.075Method of analysisFor the determination of hex-3(cis)-enal in the feed additive and in feed flavouring premixtures:Gas chromatography mass spectrometry with retention time locking GC-MS-RTLAll 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b05085—Hept-4-enalAdditive compositionHept-4-enalCharacterisation of the active substanceHept-4-enalProduced by chemical synthesisPurity: min. 98 % as sum of (Z)- and (E)-isomers; min. 93 % of (Z)-isomer; secondary component: 2-5 % (E)- isomer.Chemical formula: C7H12OCAS number: 6728-31-0FLAVIS No: 05.085Method of analysisFor the determination of hept-4-enal in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b09197—Hex-3(cis)-enyl acetateAdditive compositionHex-3(cis)-enyl acetateCharacterisation of the active substanceHex-3(cis)-enyl acetateProduced by chemical synthesisPurity: min. 98 % assay as sum of (Z)- and (E)-isomers; min. 92 % of (Z)-isomerChemical formula: C8H14O2CAS number: 3681-71-8FLAVIS No: 09.197Method of analysisFor the determination of hex-3(cis)-enyl acetate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b09240—Hex-3(cis)-enyl formateAdditive compositionHex-3(cis)-enyl formateCharacterisation of the active substanceHex-3(cis)-enyl formateProduced by chemical synthesisPurity: min. 95 % assayChemical formula: C7H12O2CAS number: 33467-73-1FLAVIS No: 09.240Method of analysisFor the determination of hex-3(cis)-enyl formate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b09270—Hex-3-enyl butyrateAdditive compositionHex-3-enyl butyrateCharacterisation of the active substanceHex-3-enyl butyrateProduced by chemical synthesisPurity: min. 95 % assayChemical formula: C10H18O2CAS number: 16491-36-4FLAVIS No: 09.270Method of analysisFor the determination of hex-3-enyl butyrate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b09271—Hex-3-enyl hexanoateAdditive compositionHex-3-enyl hexanoateCharacterisation of the active substanceHex-3-enyl hexanoateProduced by chemical synthesisPurity: min. 96 % assayChemical formula: C12H22O2CAS number: 31501-11-8FLAVIS No: 09.271Method of analysisFor the determination of hex-3-enyl hexanoate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b09563—Hex-3(cis)-enyl isobutyrateAdditive compositionHex-3(cis)-enyl isobutyrateCharacterisation of the active substanceHex-3(cis)-enyl isobutyrateProduced by chemical synthesisPurity: min. 98 % assayChemical formula: C10H18O2CAS number: 41519-23-7FLAVIS No: 09.563Method of analysisFor the determination of hex-3(cis)-enyl isobutyrate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 5 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.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.15.3.2028
2b02011—CitronellolAdditive compositionCitronellolCharacterisation of the active substanceCitronellolProduced by chemical synthesisPurity: min. 90 % assay; racemate; other constituents: diunsaturated and saturated C10 alcohols, citronellyl acetate and citronellalChemical formula: C10H20OCAS number: 106-22-9FLAVIS No: 02.011Method of analysisFor the determination of citronellol in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b02229—(-)-3,7-Dimethyl-6-octen-1-olAdditive composition(-)-3,7-Dimethyl-6-octen-1-olCharacterisation of the active substance(-)-3,7-Dimethyl-6-octen-1-olProduced by chemical synthesis or derived by fractional distillation of essential oils and saponification of extractsPurity: min. 90 % assayChemical formula: C10H20OCAS number: 7540-51-4FLAVIS No: 02.229Method of analysisFor the determination of (-)-3,7-dimethyl-6-octen-1-ol in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b05021—CitronellalAdditive compositionCitronellalCharacterisation of the active substanceCitronellalProduced by chemical synthesisPurity: min. 85 % assay.Chemical formula: C10H18OCAS number: 106-23-0FLAVIS No: 05.021Method of analysisFor the determination of citronellal in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories"5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b05074—2,6-Dimethylhept-5-enalAdditive composition2,6-Dimethylhept-5-enalCharacterisation of the active substance2,6-Dimethylhept-5-enalProduced by chemical synthesisPurity: min. 85 % assayChemical formula: C9H16OCAS number: 106-72-9FLAVIS No: 05.074Method of analysisFor the determination of 2,6-dimethylhept-5-enal in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b08036—Citronellic acidAdditive compositionCitronellic acidCharacterisation of the active substanceCitronellic acidProduced by chemical synthesisPurity: min. 90 % assayChemical formula: C10H18O2CAS number: 502-47-6FLAVIS No: 08.036Method of analysisFor the determination of citronellic acid in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b09012—Citronellyl acetateAdditive compositionCitronellyl acetateCharacterisation of the active substanceCitronellyl acetateProduced by chemical synthesisPurity: min. 92 % assayChemical formula: C11H22O2CAS number: 150-84-5FLAVIS No: 09.012Method of analysisFor the determination of citronellyl acetate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b09049—Citronellyl butyrateAdditive compositionCitronellyl butyrateCharacterisation of the active substanceCitronellyl butyrateProduced by chemical synthesisPurity: min. 90 % assayChemical formula: C14H26O2CAS number: 141-16-2FLAVIS No: 09.049Method of analysisFor the determination of citronellyl butyrate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b09078—Citronellyl formateAdditive compositionCitronellyl formateCharacterisation of the active substanceCitronellyl formateProduced by chemical synthesisPurity: min. 90 % assay.Chemical formula: C11H20O2CAS number: 105-85-1FLAVIS No: 09.078Method of analysisFor the determination of citronellyl formate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b09129—Citronellyl propionateAdditive compositionCitronellyl propionateCharacterisation of the active substanceCitronellyl propionateProduced by chemical synthesisPurity: min. 95 % assayChemical formula: C13H24O2CAS number: 141-14-0FLAVIS No: 09.129Method of analysisFor the determination of citronellyl propionate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 % shall be:1 mg/kg for cats5 mg/kg for other species and categories.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:1 mg/kg for cats5 mg/kg for other species and categories".5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds:1 mg/kg for cats5 mg/kg for other species and categories.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.15.3.2028
2b06081—1-Ethoxy-1-(3-hexenyloxy)ethaneAdditive composition1-Ethoxy-1-(3-hexenyloxy)ethaneCharacterisation of the active substance1-Ethoxy-1-(3-hexenyloxy)ethaneProduced by chemical synthesisPurity: min. 97 % assayChemical formula: C10H20O2CAS number: 28069-74-1FLAVIS No: 06.081Method of analysisFor the determination of 1-ethoxy-1-(3-hexenyloxy)ethane in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.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.15.3.2028
2b09505—Hex-3-enyl isovalerateAdditive compositionHex-3-enyl isovalerateCharacterisation of the active substanceHex-3-enyl isovalerateProduced by chemical synthesisPurity: min. 95 % assayChemical formula: C11H20O2CAS number: 10032-11-8FLAVIS No: 09.505Method of analysisFor the determination of hex-3-enyl isovalerate in the feed additive and in feed 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 and stability conditions shall be indicated.3.The recommended maximum content of the active substance shall be 1 mg/kg of complete feedingstuff with a moisture content of 12 %.4.On the label of the additive the following shall be indicated:"Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg."5.The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures and on the labelling of feed materials and compound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg.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.15.3.2028