Home Europe European Commission Commission Implementing Regulation (EU) 2018/242 of 15 Febru...
Date: 2018-02-23 Category: Not Applicable State: Union Government Country: Europe

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. )

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

**Executive Summary:** Commission Implementing Regulation (EU) 2018/242 authorises the use of several flavouring compounds as sensory feed additives for all animal species. These substances were previously authorised under Directive 70/524/EEC. The regulation includes conditions of use, labeling requirements, and transitional measures for existing stocks, with a primary focus on ensuring safety and providing clear information to users. **Key Points / Main Content:** * **Authorisation:** * The substances listed in the Annex are authorised as feed additives for all animal species. * They belong to the sensory additives category, functional group flavouring compounds. * **Conditions of Use:** * The additives should be incorporated into feed in the form of a premix. * Directions for use and storage/stability conditions must be indicated on the additive and premixtures. * A recommended maximum content of the active substance in complete feedingstuff (with 12% moisture content) is specified for each additive. * **Labeling Requirements:** * The additive label must indicate the recommended maximum content of the active substance in complete feedingstuff (with 12% moisture). * Premixtures, feed materials, and compound feedingstuffs labels must include the functional group, identification number, name, and added amount of the active substance if the content exceeds the recommended maximum. * **Safety Measures:** * Feed business operators must establish operational procedures and organizational measures to address potential inhalation, dermal contact, or eye contact risks. * Personal protective equipment (breathing protection, safety glasses, gloves) must be used if risks cannot be eliminated or minimised. * **Transitional Measures:** * Substances and premixtures produced and labelled before September 15, 2018, under the old rules (before March 15, 2018) can be placed on the market and used until existing stocks are exhausted. * Feed materials and compound feed for food-producing animals produced and labelled before March 15, 2019, under the old rules (before March 15, 2018) can be placed on the market and used until existing stocks are exhausted. * Feed materials and compound feed for non-food-producing animals produced and labelled before March 15, 2020, under the old rules (before March 15, 2018) can be placed on the market and used until existing stocks are exhausted. * **End Date of Authorisation:** * The authorisation for all listed substances ends on March 15, 2028. **Impact Analysis:** **Feed Additive Manufacturers:** * *Impact:* Must comply with the new authorisation conditions, including purity standards, recommended maximum content levels, and labeling requirements. * *Action Required:* Adjust production and labeling processes to meet the new standards. Update safety protocols for handling the additives. **Feed Business Operators (including Premixture Manufacturers):** * *Impact:* Must ensure that feed and premixtures are labeled correctly and used safely. Must establish operational procedures to minimize risks of inhalation, dermal contact, and eye contact. * *Action Required:* Implement safety measures, update labeling practices, and provide users with necessary information on safe handling. **Animal Feed Producers:** * *Impact:* Need to ensure that the feed they produce complies with the regulation, particularly regarding maximum content levels and labeling. * *Action Required:* Source additives and premixtures from compliant manufacturers, adjust feed formulations as necessary, and ensure accurate labeling of feed products. **Users of Feed Additives and Premixtures:** * *Impact:* Required to follow established operational procedures and organizational measures to address potential risks by inhalation, dermal contact or eyes contact. * *Action Required:* Use appropriate personal protective equipment where risks cannot be eliminated or reduced to a minimum.

Key Entities Referenced

European Union: A political and economic union of member states located primarily in Europe. European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Regulation (EC) No 1831/2003: A Regulation of the European Parliament and of the Council on additives for use in animal nutrition. European Parliament: The parliamentary body of the European Union. Council of the European Union: A body composed of government ministers from each EU member state. Council Directive 70/524/EEC: A Council Directive concerning additives in feedingstuffs. European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures proposed by the European Commission concerning food safety.
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L 53/36 EN Official Journal of the European Union 23.2.2018 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) 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 of that Regulation provides for the re- evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). (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 2016 (3) 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. (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 2016;14(8):4559.23.2.2018 EN Official Journal of the European Union L 53/37 (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 authoris­ ation 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 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 Transitional measures 1. 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 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, 15 February 2018. For the Commission The President Jean-Claude JUNCKERANNEX Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b02056 — Hex-3(cis)-en- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 1-ol species into the feed in the form of a pre­ Hex-3(cis)-en-1-ol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3(cis)-en-1-ol and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98 % assay as sum of tent of the active substance shall be (Z)- and (E)-isomers; min. 92 % of 5 mg/kg of complete feedingstuff (Z)-isomer with a moisture content of 12 %. Chemical formula: C H O 6 12 4. On the label of the additive the fol­ CAS number: 928-96-1 lowing shall be indicated: FLAVIS No: 02.056 ‘Recommended maximum content of the active substance of complete Method of analysis(1) feedingstuff with a moisture content For the determination of hex- of 12 %: 5 mg/kg.’ 3(cis)-en-1-ol in the feed additive 5. The functional group, the identifica­ and in feed flavouring premix­ tion number, the name and the tures: added amount of the active sub­ Gas chromatography mass spec­ stance shall be indicated on the la­ trometry with retention time lock­ bel of the premixtures and on the ing GC-MS-RTL labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. L 53/38 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b02093 — Non-6-en-1-ol Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Non-6-en-1-ol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Non-6-en-1-ol and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98 % assay tent of the active substance shall be Chemical formula: C H O 1 mg/kg of complete feedingstuff 9 18 CAS number: 35854-86-5 with a moisture content of 12 %. FLAVIS No: 02.093 4. On the label of the additive the fol­ lowing shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/39Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 5. The functional group, the identifica­ tion number, the name and the For the determination of non-6- added amount of the active sub­ en-1-ol in the feed additive and in stance shall be indicated on the la­ feed flavouring premixtures: bel of the premixtures and on the Gas chromatography mass spec­ labelling of feed materials and com­ trometry with retention time lock­ pound feedingstuffs, if the content ing GC-MS-RTL of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b02094 — Oct-3-en-1-ol Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Oct-3-en-1-ol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Oct-3-en-1-ol and stability conditions shall be in­ dicated. Produced by chemical synthesis L 53/40 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Purity: min. 96 % assay, as (Z)- 3. The recommended maximum con­ isomer. tent of the active substance shall be 1 mg/kg of complete feedingstuff Chemical formula: C H O 8 16 with a moisture content of 12 %. CAS number: 20125-84-2 4. On the label of the additive the fol­ FLAVIS No: 02.094 lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content of the active substance of complete For the determination oct-3-en-1- feedingstuff with a moisture content ol in the feed additive and in feed of 12 %: 1 mg/kg.’ flavouring premixtures: 5. The functional group, the identifica­ Gas chromatography mass spec­ tion number, the name and the trometry with retention time lock­ added amount of the active sub­ ing GC-MS-RTL stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound 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 pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 23.2.2018 EN Official Journal of the European Union L 53/41Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 2b05059 — Non-6(cis)- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 enal species into the feed in the form of a pre­ Non-6(cis)-enal mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Non-6(cis)-enal and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 96 % assay; second­ tent of the active substance shall be ary component 6–9 % trans-6- 5 mg/kg of complete feedingstuff nonenal with a moisture content of 12 %. Chemical formula: C H O 9 16 4. On the label of the additive the fol­ CAS number: 2277-19-2 lowing shall be indicated: FLAVIS No: 05.059 ‘Recommended maximum content of the active substance of complete Method of analysis(1) feedingstuff with a moisture content For the determination non-6(cis)- of 12 %: 5 mg/kg.’ enal in the feed additive and in 5. The functional group, the identifica­ feed flavouring premixtures: tion number, the name and the Gas chromatography mass spec­ added amount of the active sub­ trometry with retention time lock­ stance shall be indicated on the la­ ing GC-MS-RTL bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg L 53/42 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b05075 — Hex-3(cis)- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 enal species into the feed in the form of a pre­ Hex-3(cis)-enal mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3(cis)-enal and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 97 % assay tent of the active substance shall be Chemical formula: C H O 5 mg/kg of complete feedingstuff 6 10 CAS number: 6789-80-6 with a moisture content of 12 %. FLAVIS No: 05.075 4. On the label of the additive the fol­ lowing shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/43Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 5. The functional group, the identifica­ tion number, the name and the For the determination of hex- added amount of the active sub­ 3(cis)-enal in the feed additive and stance shall be indicated on the la­ in feed flavouring premixtures: bel of the premixtures and on the Gas chromatography mass spec­ labelling of feed materials and com­ trometry with retention time lock­ pound feedingstuffs, if the content ing GC-MS-RTL of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b05085 — Hept-4-enal Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Hept-4-enal mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hept-4-enal and stability conditions shall be in­ dicated. Produced by chemical synthesis L 53/44 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Purity: min. 98 % as sum of (Z)- 3. The recommended maximum con­ and (E)-isomers; min. 93 % of (Z)- tent of the active substance shall be isomer; secondary component: 2- 5 mg/kg of complete feedingstuff 5 % (E)- isomer. with a moisture content of 12 %. Chemical formula: C H O 4. On the label of the additive the fol­ 7 12 lowing shall be indicated: CAS number: 6728-31-0 ‘Recommended maximum content FLAVIS No: 05.085 of the active substance of complete Method of analysis(1) feedingstuff with a moisture content of 12 %: 5 mg/kg.’ For the determination of hept-4- enal in the feed additive and in 5. The functional group, the identifica­ feed flavouring premixtures: tion number, the name and the added amount of the active sub­ Gas chromatography mass spec­ stance shall be indicated on the la­ trometry with retention time lock­ bel of the premixtures and on the ing GC-MS-RTL. labelling of feed materials and com­ pound 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 pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 23.2.2018 EN Official Journal of the European Union L 53/45Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 2b09197 — Hex-3(cis)- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 enyl acetate species into the feed in the form of a pre­ Hex-3(cis)-enyl acetate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3(cis)-enyl acetate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98 % assay as sum of tent of the active substance shall be (Z)- and (E)-isomers; min. 92 % of 5 mg/kg of complete feedingstuff (Z)-isomer with a moisture content of 12 %. Chemical formula: C H O 8 14 2 4. On the label of the additive the fol­ CAS number: 3681-71-8 lowing shall be indicated: FLAVIS No: 09.197 ‘Recommended maximum content of the active substance of complete Method of analysis(1) feedingstuff with a moisture content For the determination of hex- of 12 %: 5 mg/kg.’ 3(cis)-enyl acetate in the feed addi­ 5. The functional group, the identifica­ tive and in feed flavouring pre­ tion number, the name and the mixtures: added amount of the active sub­ Gas chromatography mass spec­ stance shall be indicated on the la­ trometry with retention time lock­ bel of the premixtures and on the ing GC-MS-RTL. labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. L 53/46 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b09240 — Hex-3(cis)- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 enyl formate species into the feed in the form of a pre­ Hex-3(cis)-enyl formate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3(cis)-enyl formate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 95 % assay tent of the active substance shall be Chemical formula: C H O 5 mg/kg of complete feedingstuff 7 12 2 CAS number: 33467-73-1 with a moisture content of 12 %. FLAVIS No: 09.240 4. On the label of the additive the fol­ lowing shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/47Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 5. The functional group, the identifica­ tion number, the name and the For the determination of hex- added amount of the active sub­ 3(cis)-enyl formate in the feed ad­ stance shall be indicated on the la­ ditive and in feed flavouring pre­ bel of the premixtures and on the mixtures: labelling of feed materials and com­ Gas chromatography mass spec­ pound feedingstuffs, if the content trometry with retention time lock­ of the active substance in complete ing GC-MS-RTL. feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b09270 — Hex-3-enyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 butyrate species into the feed in the form of a pre­ Hex-3-enyl butyrate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3-enyl butyrate and stability conditions shall be in­ dicated. Produced by chemical synthesis L 53/48 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Purity: min. 95 % assay 3. The recommended maximum con­ tent of the active substance shall be Chemical formula: C H O 10 18 2 5 mg/kg of complete feedingstuff CAS number: 16491-36-4 with a moisture content of 12 %. FLAVIS No: 09.270 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of hex-3- of the active substance of complete enyl butyrate in the feed additive feedingstuff with a moisture content and in feed flavouring premix­ of 12 %: 5 mg/kg.’ tures: 5. The functional group, the identifica­ Gas chromatography mass spec­ tion number, the name and the trometry with retention time lock­ added amount of the active sub­ ing GC-MS-RTL. stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound 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 pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 23.2.2018 EN Official Journal of the European Union L 53/49Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 2b09271 — Hex-3-enyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 hexanoate species into the feed in the form of a pre­ Hex-3-enyl hexanoate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3-enyl hexanoate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 96 % assay tent of the active substance shall be Chemical formula: C H O 5 mg/kg of complete feedingstuff 12 22 2 CAS number: 31501-11-8 with a moisture content of 12 %. FLAVIS No: 09.271 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of hex-3- of the active substance of complete enyl hexanoate in the feed additive feedingstuff with a moisture content and in feed flavouring premix­ of 12 %: 5 mg/kg.’ tures: 5. The functional group, the identifica­ Gas chromatography mass spec­ tion number, the name and the trometry with retention time lock­ added amount of the active sub­ ing GC-MS-RTL. stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. L 53/50 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b09563 — Hex-3(cis)- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 enyl isobuty­ species into the feed in the form of a pre­ Hex-3(cis)-enyl isobutyrate rate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3(cis)-enyl isobutyrate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 98 % assay tent of the active substance shall be Chemical formula: C H O 5 mg/kg of complete feedingstuff 10 18 2 CAS number: 41519-23-7 with a moisture content of 12 %. FLAVIS No: 09.563 4. On the label of the additive the fol­ lowing shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/51Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 5. The functional group, the identifica­ tion number, the name and the For the determination of hex- added amount of the active sub­ 3(cis)-enyl isobutyrate in the feed stance shall be indicated on the la­ additive and in feed flavouring bel of the premixtures and on the premixtures: labelling of feed materials and com­ Gas chromatography mass spec­ pound feedingstuffs, if the content trometry with retention time lock­ of the active substance in complete ing GC-MS-RTL. feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b02011 — Citronellol Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Citronellol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Citronellol and stability conditions shall be in­ dicated. Produced by chemical synthesis L 53/52 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Purity: min. 90 % assay; racemate; 3. The recommended maximum con­ other constituents: diunsaturated tent of the active substance of com­ and saturated C10 alcohols, citro­ plete feedingstuff with a moisture nellyl acetate and citronellal content of 12 % shall be: Chemical formula: C H O — 1 mg/kg for cats 10 20 CAS number: 106-22-9 — 5 mg/kg for other species and categories. FLAVIS No: 02.011 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of citronel­ of the active substance of complete lol in the feed additive and in feed feedingstuff with a moisture content flavouring premixtures: of 12 %: Gas chromatography mass spec­ — 1 mg/kg for cats trometry with retention time lock­ ing GC-MS-RTL. — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. 23.2.2018 EN Official Journal of the European Union L 53/53Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b02229 — (-)-3,7-Di­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 methyl-6-oc­ species into the feed in the form of a pre­ (-)-3,7-Dimethyl-6-octen-1-ol ten-1-ol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage (-)-3,7-Dimethyl-6-octen-1-ol and stability conditions shall be in­ dicated. Produced by chemical synthesis or derived by fractional distillation of 3. The recommended maximum con­ essential oils and saponification of tent of the active substance of com­ extracts plete feedingstuff with a moisture content of 12 % shall be: Purity: min. 90 % assay — 1 mg/kg for cats Chemical formula: C H O 10 20 — 5 mg/kg for other species and CAS number: 7540-51-4 categories. FLAVIS No: 02.229 L 53/54 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 4. On the label of the additive the fol­ lowing shall be indicated: For the determination of (-)-3,7- dimethyl-6-octen-1-ol in the feed ‘Recommended maximum content additive and in feed flavouring of the active substance of complete premixtures: feedingstuff with a moisture content of 12 %: Gas chromatography mass spec­ trometry with retention time lock­ — 1 mg/kg for cats ing GC-MS-RTL. — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 23.2.2018 EN Official Journal of the European Union L 53/55Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 2b05021 — Citronellal Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Citronellal mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Citronellal and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 85 % assay. tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 10 18 CAS number: 106-23-0 content of 12 % shall be: FLAVIS No: 05.021 — 1 mg/kg for cats — 5 mg/kg for other species and Method of analysis(1) categories. For the determination of citronel­ 4. On the label of the additive the fol­ lal in the feed additive and in feed lowing shall be indicated: flavouring premixtures: ‘Recommended maximum content Gas chromatography mass spec­ of the active substance of complete trometry with retention time lock­ feedingstuff with a moisture content ing GC-MS-RTL. of 12 %: — 1 mg/kg for cats — 5 mg/kg for other species and categories’ 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. L 53/56 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b05074 — 2,6-Dimethyl­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 hept-5-enal species into the feed in the form of a pre­ 2,6-Dimethylhept-5-enal mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage 2,6-Dimethylhept-5-enal and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 85 % assay tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 9 16 CAS number: 106-72-9 content of 12 % shall be: FLAVIS No: 05.074 — 1 mg/kg for cats — 5 mg/kg for other species and categories. 23.2.2018 EN Official Journal of the European Union L 53/57Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 4. On the label of the additive the fol­ lowing shall be indicated: For the determination of 2,6-di­ methylhept-5-enal in the feed ad­ ‘Recommended maximum content ditive and in feed flavouring pre­ of the active substance of complete mixtures: feedingstuff with a moisture content of 12 %: Gas chromatography mass spec­ trometry with retention time lock­ — 1 mg/kg for cats ing GC-MS-RTL. — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. L 53/58 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 2b08036 — Citronellic Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 acid species into the feed in the form of a pre­ Citronellic acid mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Citronellic acid and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 90 % assay tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 10 18 2 CAS number: 502-47-6 content of 12 % shall be: FLAVIS No: 08.036 — 1 mg/kg for cats — 5 mg/kg for other species and Method of analysis(1) categories. For the determination of citronel­ 4. On the label of the additive the fol­ lic acid in the feed additive and in lowing shall be indicated: feed flavouring premixtures: ‘Recommended maximum content Gas chromatography mass spec­ of the active substance of complete trometry with retention time lock­ feedingstuff with a moisture content ing GC-MS-RTL. of 12 %: — 1 mg/kg for cats — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. 23.2.2018 EN Official Journal of the European Union L 53/59Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b09012 — Citronellyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 acetate species into the feed in the form of a pre­ Citronellyl acetate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Citronellyl acetate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 92 % assay tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 11 22 2 CAS number: 150-84-5 content of 12 % shall be: FLAVIS No: 09.012 — 1 mg/kg for cats — 5 mg/kg for other species and categories. L 53/60 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 4. On the label of the additive the fol­ lowing shall be indicated: For the determination of citronel­ lyl acetate in the feed additive and ‘Recommended maximum content in feed flavouring premixtures: of the active substance of complete feedingstuff with a moisture content Gas chromatography mass spec­ of 12 %: trometry with retention time lock­ ing GC-MS-RTL. — 1 mg/kg for cats — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 23.2.2018 EN Official Journal of the European Union L 53/61Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 2b09049 — Citronellyl bu­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 tyrate species into the feed in the form of a pre­ Citronellyl butyrate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Citronellyl butyrate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 90 % assay tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 14 26 2 CAS number: 141-16-2 content of 12 % shall be: FLAVIS No: 09.049 — 1 mg/kg for cats — 5 mg/kg for other species and Method of analysis(1) categories. For the determination of citronel­ 4. On the label of the additive the fol­ lyl butyrate in the feed additive lowing shall be indicated: and in feed flavouring premix­ tures: ‘Recommended maximum content of the active substance of complete Gas chromatography mass spec­ feedingstuff with a moisture content trometry with retention time lock­ of 12 %: ing GC-MS-RTL. — 1 mg/kg for cats — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. L 53/62 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b09078 — Citronellyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 formate species into the feed in the form of a pre­ Citronellyl formate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Citronellyl formate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 90 % assay. tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 11 20 2 CAS number: 105-85-1 content of 12 % shall be: FLAVIS No: 09.078 — 1 mg/kg for cats — 5 mg/kg for other species and categories. 23.2.2018 EN Official Journal of the European Union L 53/63Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 4. On the label of the additive the fol­ lowing shall be indicated: For the determination of citronel­ lyl formate in the feed additive ‘Recommended maximum content and in feed flavouring premix­ of the active substance of complete tures: feedingstuff with a moisture content of 12 %: Gas chromatography mass spec­ trometry with retention time lock­ — 1 mg/kg for cats ing GC-MS-RTL. — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. L 53/64 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 2b09129 — Citronellyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 propionate species into the feed in the form of a pre­ Citronellyl propionate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Citronellyl propionate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 95 % assay tent of the active substance of com­ Chemical formula: C H O plete feedingstuff with a moisture 13 24 2 CAS number: 141-14-0 content of 12 % shall be: FLAVIS No: 09.129 — 1 mg/kg for cats — 5 mg/kg for other species and Method of analysis(1) categories. For the determination of citronel­ 4. On the label of the additive the fol­ lyl propionate in the feed additive lowing shall be indicated: and in feed flavouring premix­ tures: ‘Recommended maximum content of the active substance of complete Gas chromatography mass spec­ feedingstuff with a moisture content trometry with retention time lock­ of 12 %: ing GC-MS-RTL. — 1 mg/kg for cats — 5 mg/kg for other species and categories’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound feedingstuffs, if the content of the active substance in complete feedingstuff with a moisture content of 12 % exceeds: — 1 mg/kg for cats — 5 mg/kg for other species and categories. 23.2.2018 EN Official Journal of the European Union L 53/65Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b06081 — 1-Ethoxy- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 1-(3-hexeny­ species into the feed in the form of a pre­ 1-Ethoxy-1-(3-hexenyloxy)ethane loxy)ethane mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage 1-Ethoxy-1-(3-hexenyloxy)ethane and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. The recommended maximum con­ Purity: min. 97 % assay tent of the active substance shall be Chemical formula: C H O 1 mg/kg of complete feedingstuff 10 20 2 CAS number: 28069-74-1 with a moisture content of 12 %. FLAVIS No: 06.081 4. On the label of the additive the fol­ lowing shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg.’ L 53/66 EN Official Journal of the European Union 23.2.2018Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Method of analysis(1) 5. The functional group, the identifica­ tion number, the name and the For the determination of 1- added amount of the active sub­ ethoxy-1-(3-hexenyloxy)ethane in stance shall be indicated on the la­ the feed additive and in feed fla­ bel of the premixtures and on the vouring premixtures: labelling of feed materials and com­ Gas chromatography mass spec­ pound feedingstuffs, if the content trometry with retention time lock­ of the active substance in complete ing GC-MS-RTL. feedingstuff with a moisture content of 12 % exceeds: 1 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b09505 — Hex-3-enyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 isovalerate species into the feed in the form of a pre­ Hex-3-enyl isovalerate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Hex-3-enyl isovalerate and stability conditions shall be in­ dicated. Produced by chemical synthesis 23.2.2018 EN Official Journal of the European Union L 53/67Minimum Maximum Identifica­ Name of content content End of Species or tion the holder Additive Composition, chemical formula, category of Maximum mg of active substance/kg Other provisions period of number of of authoris­ description, analytical method animal age of complete feedingstuff authoris­ the additive ation with a moisture content of ation 12 % Purity: min. 95 % assay 3. The recommended maximum con­ tent of the active substance shall be Chemical formula: C H O 11 20 2 1 mg/kg of complete feedingstuff CAS number: 10032-11-8 with a moisture content of 12 %. FLAVIS No: 09.505 4. On the label of the additive the fol­ lowing shall be indicated: Method of analysis(1) ‘Recommended maximum content For the determination of hex-3- of the active substance of complete enyl isovalerate in the feed addi­ feedingstuff with a moisture content tive and in feed flavouring pre­ of 12 %: 1 mg/kg.’ mixtures: 5. The functional group, the identifica­ Gas chromatography mass spec­ tion number, the name and the trometry with retention time lock­ added amount of the active sub­ ing GC-MS-RTL. stance shall be indicated on the la­ bel of the premixtures and on the labelling of feed materials and com­ pound 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 pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimin­ ated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. (1) 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. L 53/68 EN Official Journal of the European Union 23.2.2018

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