Home Europe European Commission Commission Implementing Regulation (EU) 2018/250 of 15 Febru...
Date: 2018-02-23 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate 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) 2018/250 authorises methyl 2-furoate, bis(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide, and furfuryl acetate as sensory feed additives for all animal species. The regulation includes transitional measures for products produced and labelled before specific dates in 2018, with deadlines in 2019 and 2020 for feed materials and compound feed. The regulation went into force on March 15, 2018. Key Points / Main Content: * **Authorisation of Feed Additives:** * The specified substances are authorised as feed additives for all animal species, classified as sensory additives (flavouring compounds). * The authorisation is subject to the conditions outlined in the Annex of the Regulation. * The end date of authorisation for all listed substances is March 15, 2028. * **Conditions of Use and Labelling Requirements:** * The additives must be incorporated into feed in the form of a premixture. * Storage and stability conditions must be indicated in the directions for use of the additive and premixtures. * The label of the additive must include the recommended maximum content of the active substance in complete feedingstuff (12% moisture). * For premixtures, if the suggested use level exceeds the Authority's considered safe levels, the label must indicate the functional group, identification number, name, and added amount of the active substance. * For feed materials and compound feedingstuffs, the labelling must include the functional group, identification number, name, and added amount of the active substance if the content in the complete feedingstuff (12% moisture) exceeds the specified limit. * **Safety Measures:** * Feed business operators must establish operational procedures and organisational measures to address potential risks of inhalation, dermal contact, or eye contact for users of the additive and premixtures. * Personal protective equipment, including breathing protection, safety glasses, and gloves, must be used if risks cannot be eliminated or minimised. * **Transitional Measures:** * Additives and premixtures produced and labelled before September 15, 2018, according to previous rules, can continue to be placed on the market and used until existing stocks are exhausted. * Feed materials and compound feed for food-producing animals, containing the substances, produced and labelled before March 15, 2019, according to previous rules, can continue to be placed on the market and used until existing stocks are exhausted. * Feed materials and compound feed for non-food-producing animals, containing the substances, produced and labelled before March 15, 2020, according to previous rules, can continue to be placed on the market and used until existing stocks are exhausted. Impact Analysis: * **Feed Additive Manufacturers:** * *Impact:* Must comply with the new authorisation conditions, including labelling and safety requirements. * *Action Required:* Adjust production and labelling processes to meet the specifications in the Annex and ensure safety measures are in place for users. * **Feed Business Operators:** * *Impact:* Need to implement operational procedures and organisational measures to mitigate risks associated with the use of these additives. * *Action Required:* Establish and enforce safety protocols, including the use of personal protective equipment, and ensure proper labelling of premixtures, feed materials, and compound feedingstuffs. * **Animal Feed Industry (including Premixture Producers):** * *Impact:* Must adhere to the updated regulations regarding the composition and use of the specified feed additives. * *Action Required:* Update formulations, labelling, and usage instructions to align with the new requirements and ensure compliance within the specified transitional periods. * **Official Control Authorities:** * *Impact:* Responsible for enforcing the regulation and ensuring compliance along the food chain. * *Action Required:* Monitor and verify that feed additives, premixtures, feed materials, and compound feed comply with the new authorisation conditions and labelling requirements.

Key Entities Referenced

European Union: A political and economic union of member states located primarily in Europe. European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations. Treaty on the Functioning of the European Union: One of the primary treaties forming the constitutional basis of the European Union. European Parliament: The directly elected parliamentary body of the European Union. Council Directive 70524EEC: A directive concerning additives in feedingstuffs. Regulation EC No 18312003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition. 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 related to food and feed safety.
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L 53/166 EN Official Journal of the European Union 23.2.2018 COMMISSION IMPLEMENTING REGULATION (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate 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 methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate (‘substances concerned’) were authorised without a time limit by 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 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 26 January 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. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for drinking. (5) The Authority further noted that for the substances concerned 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. (6) 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. (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(2):4389.23.2.2018 EN Official Journal of the European Union L 53/167 (7) The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority. (8) The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water. (9) 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. (10) 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 feed 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.L 53/168 EN Official Journal of the European Union 23.2.2018 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 content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b13002 — Methyl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 2-furoate species into the feed in the form of a pre­ Methyl 2-furoate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Methyl 2-furoate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 98 % assay lowing shall be indicated: Chemical formula: C H O 6 6 3 ‘Recommended maximum content CAS number: 611-13-2 of the active substance of complete FLAVIS No: 13.002 feedingstuff with a moisture content of 12 %: 0,5 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of methyl tion number, the name and the 2-furoate in the feed additive and added amount of the active sub­ in feed flavouring premixtures: stance shall be indicated on the la­ Gas chromatography mass spec­ bel of the premixtures where the use trometry with retention time lock­ level suggested on the label of the ing GC-MS-RTL premixture would result in exceed­ ing the level referred to in point 3. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/169Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 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. 2b13016 — Bis-(2-methyl- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 3-furyl) disul­ species into the feed in the form of a pre­ Bis-(2-methyl-3-furyl) disulfide fide mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Bis-(2-methyl-3-furyl) disulfide and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 98 % assay lowing shall be indicated: Chemical formula: C H O S 10 10 2 2 ‘Recommended maximum content CAS number: 28588-75-2 of the active substance of complete FLAVIS No: 13.016 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of tion number, the name and the bis-(2-methyl-3-furyl) disulfide in added amount of the active sub­ the feed additive and in feed fla­ stance shall be indicated on the la­ vouring premixtures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL ing the level referred to in point 3. L 53/170 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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. 2b13018 — Furfural Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 species into the feed in the form of a pre­ Furfural mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Furfural and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 95 % assay lowing shall be indicated: Chemical formula: C H O 5 4 2 ‘Recommended maximum content CAS number: 98-01-1 of the active substance of complete FLAVIS No: 13.018 feedingstuff with a moisture content of 12 %: 5 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/171Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % Method of analysis(1) 4. The functional group, the identifica­ tion number, the name and the For the determination of furfural added amount of the active sub­ in the feed additive and in feed stance shall be indicated on the la­ flavouring premixtures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL ing the level referred to in point 3. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the 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. L 53/172 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % 2b13019 — Furfuryl alco­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 hol species into the feed in the form of a pre­ Furfuryl alcohol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Furfuryl alcohol and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 97 % assay lowing shall be indicated: Chemical formula: C H O 5 6 2 ‘Recommended maximum content CAS number: 98-00-0 of the active substance of complete FLAVIS No: 13.019 feedingstuff with a moisture content of 12 %: 5 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of furfuryl tion number, the name and the alcohol in the feed additive and in added amount of the active sub­ feed flavouring premixtures: stance shall be indicated on the la­ Gas chromatography mass spec­ bel of the premixtures where the use trometry with retention time lock­ level suggested on the label of the ing GC-MS-RTL premixture would result in exceed­ ing the level referred to in point 3. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/173Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 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. 2b13026 — 2-Furan­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 methanethiol species into the feed in the form of a pre­ 2-Furanmethanethiol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage 2-Furanmethanethiol and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 97 % assay lowing shall be indicated: Chemical formula: C H OS 5 6 ‘Recommended maximum content CAS number: 98-02-2 of the active substance of complete FLAVIS No: 13.026 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of 2-furan­ tion number, the name and the methanethiol in the feed additive added amount of the active sub­ and in feed flavouring premix­ stance shall be indicated on the la­ tures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL ing the level referred to in point 3. L 53/174 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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. 2b13033 — S-Furfuryl Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 acetothioate species into the feed in the form of a pre­ S-furfuryl acetothioate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage S-furfuryl acetothioate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 95 % assay lowing shall be indicated: Chemical formula: C H O S 7 8 2 ‘Recommended maximum content CAS number: 13678-68-7 of the active substance of complete FLAVIS No: 13.033 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/175Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % Method of analysis(1) 4. The functional group, the identifica­ tion number, the name and the For the determination of S-fur­ added amount of the active sub­ furyl acetothioate in the feed addi­ stance shall be indicated on the la­ tive and in feed flavouring pre­ bel of the premixtures where the use mixtures: level suggested on the label of the Gas chromatography mass spec­ premixture would result in exceed­ trometry with retention time lock­ ing the level referred to in point 3. ing GC-MS-RTL. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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. L 53/176 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % 2b13050 — Difurfuryl di­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 sulfide species into the feed in the form of a pre­ Difurfuryl disulfide mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Difurfuryl disulfide and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 96 % assay lowing shall be indicated: Chemical formula: C H O S 10 10 2 2 ‘Recommended maximum content CAS number: 4437-20-1 of the active substance of complete FLAVIS No: 13.050 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of difur­ tion number, the name and the furyl disulfide in the feed additive added amount of the active sub­ and in feed flavouring premix­ stance shall be indicated on the la­ tures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL. ing the level referred to in point 3. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/177Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 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. 2b13053 — Methyl fur­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 furyl sulfide species into the feed in the form of a pre­ Methyl furfuryl sulfide mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Methyl furfuryl sulfide and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 97 % assay lowing shall be indicated: Chemical formula: C H OS 6 8 ‘Recommended maximum content CAS number: 1438-91-1 of the active substance of complete FLAVIS No: 13.053 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of methyl tion number, the name and the furfuryl sulfide in the feed additive added amount of the active sub­ and in feed flavouring premix­ stance shall be indicated on the la­ tures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL. ing the level referred to in point 3. L 53/178 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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. 2b13055 — 2-Methyl­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 furan-3-thiol species into the feed in the form of a pre­ 2-Methylfuran-3-thiol mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage 2-Methylfuran-3-thiol and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 95 % assay lowing shall be indicated: Chemical formula: C H OS 5 6 ‘Recommended maximum content CAS number: 28588-74-1 of the active substance of complete FLAVIS No: 13.055 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/179Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % Method of analysis(1) 4. The functional group, the identifica­ tion number, the name and the For the determination of added amount of the active sub­ 2-methylfuran-3-thiol in the feed stance shall be indicated on the la­ additive and in feed flavouring bel of the premixtures where the use premixtures: level suggested on the label of the Gas chromatography mass spec­ premixture would result in exceed­ trometry with retention time lock­ ing the level referred to in point 3. ing GC-MS-RTL. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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. L 53/180 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % 2b13064 — Methyl fur­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 furyl disulfide species into the feed in the form of a pre­ Methyl furfuryl disulfide mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Methyl furfuryl disulfide and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 95 % assay lowing shall be indicated: Chemical formula: C H OS 6 8 2 ‘Recommended maximum content CAS number: 57500-00-2 of the active substance of complete FLAVIS No: 13.064 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of methyl tion number, the name and the furfuryl disulfide in the feed addi­ added amount of the active sub­ tive and in feed flavouring pre­ stance shall be indicated on the la­ mixtures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL. ing the level referred to in point 3. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg. 23.2.2018 EN Official Journal of the European Union L 53/181Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 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. 2b13079 — Methyl 2- Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 methyl-3-furyl species into the feed in the form of a pre­ Methyl 2-methyl-3-furyl disulfide disulfide mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Methyl 2-methyl-3-furyl disulfide and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 97 % assay lowing shall be indicated: Chemical formula: C H OS 6 8 2 ‘Recommended maximum content CAS number: 65505-17-1 of the active substance of complete FLAVIS No: 13.079 feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’ Method of analysis(1) 4. The functional group, the identifica­ For the determination of methyl tion number, the name and the 2-methyl-3-furyl disulfide in the added amount of the active sub­ feed additive and in feed flavour­ stance shall be indicated on the la­ ing premixtures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL. ing the level referred to in point 3. L 53/182 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 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. 2b13128 — Furfuryl acet­ Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 ate species into the feed in the form of a pre­ Furfuryl acetate mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Furfuryl acetate and stability conditions shall be in­ dicated. Produced by chemical synthesis 3. On the label of the additive the fol­ Purity: min. 97 % assay lowing shall be indicated: Chemical formula: C H O 7 8 3 ‘Recommended maximum content CAS number: 623-17-6 of the active substance of complete FLAVIS No: 13.128 feedingstuff with a moisture content of 12 %: 0,5 mg/kg.’ 23.2.2018 EN Official Journal of the European Union L 53/183Minimum Maximum content content Identifica­ Name of End of Species or tion the holder Composition, chemical formula, Maximum period Additive category of mg of active substance/kg Other provisions number of of authorisa­ description, analytical method age of authorisa­ animal of complete feedingstuff the additive tion tion with a moisture content of 12 % Method of analysis(1) 4. The functional group, the identifica­ tion number, the name and the For the determination of furfuryl added amount of the active sub­ acetate in the feed additive and in stance shall be indicated on the la­ feed flavouring premixtures: bel of the premixtures where the use Gas chromatography mass spec­ level suggested on the label of the trometry with retention time lock­ premixture would result in exceed­ ing GC-MS-RTL. ing the level referred to in point 3. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated in the la­ belling of feed materials and com­ pound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 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. (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 53/184 EN Official Journal of the European Union 23.2.2018

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