COMMISSION IMPLEMENTING REGULATION (EU) 2017/62

17.1.2017 | EN | Official Journal of the European Union | L 13/186 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2017/62 of 14 December 2016 concerning the authorisation of 3-(methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane 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) | 3-(Methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3-oxathiane (‘the substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products 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 those additives to 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 17 April 2013 (3) that, under the proposed conditions of use in feed the substances concerned do not have adverse effects on animal health, human health or the environment. For allyl isothiocyanate, the Authority stated that, although additional exposure to that substance through its low use level in animal feeds would not substantially increase consumer exposure, the estimated exposure of consumers is already higher than the acceptable daily intake. For allyl isothiocyanate and 2-methylpropane-1-thiol maximum contents should be set up to ensure consumer safety and environmental protection, respectively. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority could not conclude on the safety of the substances concerned used in water for drinking. However, those substances can be used within compound feeds which are subsequently administered via water. ---|--- (5) | Restrictions and conditions should be provided for to allow better control. For all the substances except allyl isothiocyanate and 2-methylpropane-1-thiol, since safety reasons do not require the setting of a maximum content and, taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials. ---|--- (6) | The Authority concluded that the substances concerned are to be considered as being irritant to skin, eyes and respiratory tract and as a skin sensitiser. 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 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 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted. 2\. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3\. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 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, 14 December 2016. For the Commission The President Jean-Claude JUNCKER * * * (1) OJ L 268, 18.10.2003, p. 29. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1). (3) EFSA Journal 2013;11(5):3208. * * * ANNEX Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|---|--- mg of active substance/kg of complete feedingstuff with a moisture content of 12 % (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) Category: Sensory additives. Functional group: Flavouring compounds 2b12001 | — | 3-(Methylthio)propionaldehyde | Additive composition 3-(Methylthio) propionaldehyde Characterisation of the active substance 3-(Methylthio) propionaldehyde Produced by chemical synthesis Purity: min. 98 % Chemical formula: C4H8OS CAS number 3268-49-3 FLAVIS No 12.001 Method of analysis (1) For the determination of 3-(methylthio) propionaldehyde 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12002 | — | Methyl 3-(methylthio)propionate | Additive composition Methyl 3-(methylthio)propionate Characterisation of the active substance Methyl 3-(methylthio)propionate Produced by chemical synthesis Purity: min. 97 % Chemical formula: C5H10O2S CAS number 13532-18-8 FLAVIS No 12.002 Method of analysis (1) For the determination of methyl 3-(methylthio)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 shall be: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12004 | — | Allylthiol | Additive composition Allylthiol Characterisation of the active substance Allylthiol Produced by chemical synthesis Purity: min. 75 % (min. 98 % allylthiol + allyl sulphide + allyl mercaptan) Chemical formula: C3H6S CAS number 870-23-5 FLAVIS No 12.004 Method of analysis (1) For the determination of allylthiol 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12006 | — | Dimethyl sulfide | Additive composition Dimethyl sulfide Characterisation of the active substance Dimethyl sulfide Produced by chemical synthesis Purity: min. 95 % Chemical formula: C2H6S CAS number 75-18-3 FLAVIS No 12.006 Method of analysis (1) For the determination of dimethyl sulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12007 | — | Dibutyl sulfide | Additive composition Dibutyl sulfide Characterisation of the active substance Dibutyl sulfide Produced by chemical synthesis Purity: min. 95 % Chemical formula: C8H18S CAS number 544-40-1 FLAVIS No 12.007 Method of analysis (1) For the determination of dibutyl sulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12008 | — | Diallyl disulfide | Additive composition Diallyl disulfide Characterisation of the active substance Diallyl disulfide Produced by chemical synthesis Purity: min. 80 % (min. 98 % diallyl disulphide +allyl sulphide + allyl mercaptan) Chemical formula: C6H10S2 CAS number 2179-57-9 FLAVIS No 12.008 Method of analysis (1) For the determination of diallyl disulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12009 | — | Diallyl trisulfide | Additive composition Diallyl trisulfide Characterisation of the active substance Diallyl trisulfide Produced by chemical synthesis Purity: min. 65 % (min.95 % allyl di-, tri- and tetra sulfides) Chemical formula: C6H10S3 CAS number 2050-87-5 FLAVIS No 12.009 Method of analysis (1) For the determination of diallyl trisulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12013 | — | Dimethyl trisulfide | Additive composition Dimethyl trisulfide Characterisation of the active substance Dimethyl trisulfide Produced by chemical synthesis Purity: min. 97 % Chemical formula: C2H6S3 CAS number 3658-80-8 FLAVIS No 12.013 Method of analysis (1) For the determination of dimethyl trisulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12014 | — | Dipropyl disulfide | Additive composition Dipropyl disulfide Characterisation of the active substance Dipropyl disulfide Produced by chemical synthesis Purity: min. 98 % Chemical formula: C6H14S2 CAS number 629-19-6 FLAVIS No 12.014 Method of analysis (1) For the determination of dipropyl disulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12025 | — | Allyl isothiocyanate | Additive composition Allyl isothiocyanate Characterisation of the active substance Allyl isothiocyanate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C4H5NS CAS number 57-06-7 FLAVIS No 12.025 Method of analysis (1) For the identification of allyl isothiocyanate in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | 0,05 | | 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. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves. ---|--- 6 February 2027 2b12026 | — | Dimethyl disulfide | Additive composition Dimethyl disulfide Characterisation of the active substance Dimethyl disulfide Produced by chemical synthesis Purity: min. 97 % Chemical formula: C2H6S2 CAS number 624-92-0 FLAVIS No 12.026 Method of analysis (1) For the determination of dimethyl disulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12027 | — | 2-Methylbenzene-1-thiol | Additive composition 2-Methylbenzene-1-thiol Characterisation of the active substance 2-Methylbenzene-1-thiol Produced by chemical synthesis Purity: min. 95 % Chemical formula: C7H8S CAS number 137-06-4 FLAVIS No 12.027 Method of analysis (1) For the determination of 2-methylbenzene-1-thiol 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12032 | — | S-Methyl butanethioate | Additive composition S-Methyl butanethioate Characterisation of the active substance S-Methyl butanethioate Produced by chemical synthesis Purity: min. 98 % Chemical formula: C5H10OS CAS number 2432-51-1 FLAVIS No 12.032 Method of analysis (1) For the determination of S-methyl butanethioate 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12037 | — | Allyl methyl disulfide | Additive composition Allyl methyl disulfide Characterisation of the active substance Allyl methyl disulfide Produced by chemical synthesis Purity: min. 90 % Chemical formula: C4H8S2 CAS number 2179-58-0 FLAVIS No 12.037 Method of analysis (1) For the determination of allyl methyl disulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12062 | — | 3-(Methylthio)propan-1-ol | Additive composition 3-(Methylthio)propan-1-ol Characterisation of the active substance 3-(Methylthio)propan-1-ol Produced by chemical synthesis Purity: min. 98 % Chemical formula: C4H10OS CAS number 505-10-2 FLAVIS No 12.062 Method of analysis (1) For the determination of 3-(methylthio)propan-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 shall be: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12063 | — | 3-(Methylthio)hexan-1-ol | Additive composition 3-(Methylthio)hexan-1-ol Characterisation of the active substance 3-(Methylthio)hexan-1-ol Produced by chemical synthesis Purity: min. 97 % Chemical formula: C7H16OS CAS number 51755-66-9 FLAVIS No 12.063 Method of analysis (1) For the determination of 3-(methylthio)hexan-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 shall be: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12071 | — | 1-Propane-1-thiol | Additive composition 1-Propane-1-thiol Characterisation of the active substance 1-Propane-1-thiol Produced by chemical synthesis Purity: min. 97 % Chemical formula: C3H8S CAS number 107-03-9 FLAVIS No 12.071 Method of analysis (1) For the determination of 1-propane-1-thiol 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12088 | — | Diallyl sulfide | Additive composition Diallyl sulfide Characterisation of the active substance Diallyl sulfide Produced by chemical synthesis Purity: min. 97 % Chemical formula: C6H10S CAS number 592-88-1 FLAVIS No 12.088 Method of analysis (1) For the determination of diallyl sulfide 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12118 | — | 2,4-Dithiapentane | Additive composition 2,4-Dithiapentane Characterisation of the active substance 2,4-Dithiapentane Produced by chemical synthesis Purity: min. 99 % Chemical formula: C3H8S2 CAS number 1618-26-4 FLAVIS No 12.118 Method of analysis (1) For the determination of 2,4-dithiapentane 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12168 | — | 2-Methyl-2-(methyldithio) propanal | Additive composition 2-Methyl-2-(methyldithio)propanal Characterisation of the active substance 2-Methyl-2-(methyldithio)propanal Produced by chemical synthesis Purity: min. 95 % Chemical formula: C5H10OS2 CAS number 67952-60-7 FLAVIS No 12.168 Method of analysis (1) For the determination of 2-methyl-2-(methyldithio) propanal 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12173 | — | 2-Methylpropane-1-thiol | Additive composition 2-Methylpropane-1-thiol Characterisation of the active substance 2-Methylpropane-1-thiol Produced by chemical synthesis Purity: min. 97 % Chemical formula: C4H10S CAS number 513-44-0 FLAVIS No 12.173 Method of analysis (1) For the identification of 2-methylpropane-1-thiol in the feed additive and flavouring premixtures: Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. | All animal species | — | — | 0,04 | | 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. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by 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 safety glasses and gloves. ---|--- 6 February 2027 2b12175 | — | Methylsulfinyl methane | Additive composition Methylsulfinylmethane Characterisation of the active substance Methylsulfinylmethane Produced by chemical synthesis Purity: min. 99 % Chemical formula: C2H6OS CAS number 67-68-5 FLAVIS No 12.175 Method of analysis (1) For the determination of methylsulfinylmethane 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b12197 | — | Propane-2-thiol | Additive composition Propane-2-thiol Characterisation of the active substance Propane-2-thiol Produced by chemical synthesis Purity: min. 98 % Chemical formula: C3H8S CAS number 75-33-2 FLAVIS No 12.197 Method of analysis (1) For the determination of propane-2-thiol 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b15025 | — | 3,5-Dimethyl-1,2,4-trithiolane | Additive composition 3,5-Dimethyl-1,2,4-trithiolane Characterisation of the active substance 3,5-Dimethyl-1,2,4-trithiolane Produced by chemical synthesis Purity: min. 90 % Secondary components: diethyl trisulphide, dimethylbenzylcarbinol, N,N-dimethyl-ethanethioamide, 4,6-dimethyl1,2,3,5-tetracyclohexane, 3-methyl-1,2,4-trithiolane, 2-methyl-4-propyl 1,3-oxathiane Chemical formula: C4H8S3 CAS number 23654-92-4 FLAVIS No 15.025 Method of analysis (1) For the determination of 3,5-dimethyl-1,2,4-trithiolane 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 2b16030 | — | 2-Methyl-4-propyl-1,3-oxathiane | Additive composition 2-Methyl-4-propyl-1,3-oxathiane Characterisation of the active substance 2-Methyl-4-propyl-1,3-oxathiane Produced by chemical synthesis Purity: min. 98 % Chemical formula: C8H16OS CAS number 67715-80-4 FLAVIS No 16.030 Method of analysis (1) For the determination of 2-methyl-4-propyl-1,3-oxathiane 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: 0,05 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 %: 0,05 mg/kg’. ---|--- 5. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 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 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 safety glasses and gloves. ---|--- 6 February 2027 * * * (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 * * *